<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02184494</url>
  </required_header>
  <id_info>
    <org_study_id>2014:12658</org_study_id>
    <secondary_id>HPN</secondary_id>
    <nct_id>NCT02184494</nct_id>
  </id_info>
  <brief_title>Blood Lactate Concentrations With and Without Exercise in Parkinson's Disease and Multiple Sclerosis Patients</brief_title>
  <acronym>PDMSLac</acronym>
  <official_title>Phase 1 Study of A Double-Blind Placebo-Controlled Study of the Effect of Beta-Alanine and Whole Body Vibration on Neurologic Motoric Function, Vascular Function, and Quality of Life in Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's&#xD;
      Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of&#xD;
      disorder-related fatigue, however, it is unknown whether PD or MS patients experience&#xD;
      compromised blood lactate responses to an acute bout of exercise, subjecting them to&#xD;
      exercise-related fatigue. These populations may experience higher energy expenditure at rest&#xD;
      due to increased rigidity, however, limited data exists investigating resting energy&#xD;
      expenditure in these populations.&#xD;
&#xD;
      Researchers hypothesize that PD and MS patients will display higher resting energy&#xD;
      expenditure than healthy age-matched controls, and that level of energy expenditure will&#xD;
      correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of&#xD;
      lactate will not be different between PD/MS and control groups, but post-exercise blood&#xD;
      lactate levels will be significantly higher in the PD/MS groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with Parkinson's Disease (PD) and Multiple Sclerosis (MS) frequently&#xD;
      experience increased levels of muscle weakness and fatigue; This impairment is exacerbated&#xD;
      with onset of exercise and alleviated with rest or sleep . Importantly, in about 1/3 of PD&#xD;
      patients, fatigue is considered debilitating , and even further, there is inconclusive&#xD;
      evidence suggesting that anti-PD and anti-MS drugs improve fatigue. The precise mechanisms&#xD;
      and pathogenesis of the disorder-specific fatigue in PD and MS remain elusive.&#xD;
&#xD;
      Both peripheral and central cholinergic systems are affected in PD , however, it has been&#xD;
      shown that peripheral cholinergic neurons at the neuromuscular junction are normal&#xD;
      functioning . Even so, recruitment of necessary motor units may be greatly affected due to&#xD;
      peripheral neuropathy common in both PD and MS . Following repetitive nerve stimulation in PD&#xD;
      and MS, there is consistent evidence of a decrease in the number of functioning motor units&#xD;
      and decrements in muscle responses. This promotes progressive fatigue with decrements in the&#xD;
      amplitude of movement. Therefore, recruitment of motor units may be a major cause of rapid&#xD;
      fatigue in repetitive movement with PD and MS patients, even though peripheral neuromuscular&#xD;
      junctions do not seem to be affected. In addition to skeletal muscle inefficiency, work rate&#xD;
      and efficiency of breathing using respiratory muscles is significantly lower in a PD&#xD;
      population during repetitive stimulation, used to simulate exercise-induced repetitive&#xD;
      contractions. Respiratory inefficiencies in MS include, but are not limited to reduced forced&#xD;
      vital capacity, hypoxemia, and respiratory muscle weakness.&#xD;
&#xD;
      In addition to possible neurological mechanisms of PD- and MS-related fatigue, rigidity,&#xD;
      defined as involuntary state of continuous muscle tension in PD, and spasticity and rigidity&#xD;
      in MS may also have a profound effect on fatigue outcomes . Adequate muscle length is&#xD;
      required for effective muscle contraction. Rigidity likely changes the length of the muscle&#xD;
      at rest, and therefore contributes to ineffective muscle contraction when active. In addition&#xD;
      to inefficient muscle contraction, the increased continuous active contraction, or tone, of&#xD;
      the muscle results in an increase in resting energy expenditure compared to healthy&#xD;
      individuals, even in pharmacologically treated PD patients. Interestingly, resting energy&#xD;
      expenditure in MS patients was shown to be comparable to age-matched healthy controls;&#xD;
      however, it is important to note that these MS patients remained medicated during the study.&#xD;
      In addition, rigidity and spasticity, common in PD and MS, respectively may provide varying&#xD;
      levels of resting energy expenditure; however, no research to date has examined these&#xD;
      differences. In total, if more energy is being expended at rest, hypothetically, PD and MS&#xD;
      patients will have inadequate energy stores to exercise to their respective full capacity.&#xD;
      This could potentiate early onset of lactic acid and hydrogen accumulation in active muscle,&#xD;
      decrease the pH of the active muscle, and contribute to early fatigue in repetitive tasks.&#xD;
&#xD;
      Purportedly, the combination of early onset of skeletal and respiratory muscle fatigue, in&#xD;
      addition to muscle rigidity would create an environment similar to that of high intensity&#xD;
      exercise, even at low intensities or rest. The ensuing result may likely be an accumulation&#xD;
      of lactic acid and hydrogen ions, making the muscle environment very acidic. However, changes&#xD;
      in the levels of resting and post-exercise blood lactate levels have not been elucidated.&#xD;
      Therefore, we are planning to measure resting energy expenditure using a ventilation face&#xD;
      mask and a noseclip. Blood lactate will be sampled at rest, after simulated high-intensity&#xD;
      exercise, and ten minutes after rest (when lactate significantly increases). The exercise&#xD;
      will consist of performing 5 sets of static, shallow 120 degree squats for 1 minute, with 1&#xD;
      minute of seated rest between each squat. Sustained isometric contraction at 2/3 of the&#xD;
      maximal voluntary contractile force for 2 to 3 minutes was found to occlude local blood flow&#xD;
      enough that local oxygen stores were depleted . Muscle lactate is also increased 12-fold upon&#xD;
      fatigue of isometric holds such as squats. This same environment of lactic acid buildup can&#xD;
      be simulated by circulatory occlusion as well as 60-second isometric quadricep contractions .&#xD;
      Isometric squats will be employed to observe differences in blood response in PD compared to&#xD;
      healthy individuals.&#xD;
&#xD;
      Therefore, the purpose of this study is to analyze the differences in resting energy&#xD;
      expenditure and exercise-induced lactate production in PD and MS compared to healthy,&#xD;
      age-matched controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Lactate Response</measure>
    <time_frame>Before, immediately after, and 10 minutes after the squatting exercise protocol</time_frame>
    <description>Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting Energy Expenditure</measure>
    <time_frame>Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.</time_frame>
    <description>Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Neurological Function</measure>
    <time_frame>Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.</time_frame>
    <description>Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health and Activity Questionnaire</measure>
    <time_frame>Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.</time_frame>
    <description>Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.&#xD;
Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue/Depression Assessment</measure>
    <time_frame>Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.</time_frame>
    <description>Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.&#xD;
Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Blood Lactate Response in PD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood Lactate Response in MS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood Lactate Responses in Controls</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)</intervention_name>
    <description>Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
    <arm_group_label>Blood Lactate Response in MS</arm_group_label>
    <arm_group_label>Blood Lactate Response in PD</arm_group_label>
    <arm_group_label>Blood Lactate Responses in Controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's Disease Stage I-IV (be standard criteria H&amp;Y scale)&#xD;
&#xD;
          -  Multiple Sclerosis&#xD;
&#xD;
          -  Healthy, age-matched controls&#xD;
&#xD;
          -  45 to 90 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Co-morbid neurologic factors&#xD;
&#xD;
          -  Individuals without independent ambulation&#xD;
&#xD;
          -  Significant heart and respiratory disease&#xD;
&#xD;
          -  Debilitating arthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Ormsbee, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fitness and Wellness Center</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Balance Disorders Clinic</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>July 2, 2015</results_first_submitted>
  <results_first_submitted_qc>October 15, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 16, 2015</results_first_posted>
  <last_update_submitted>March 7, 2017</last_update_submitted>
  <last_update_submitted_qc>March 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Michael J. Ormsbee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Resting Energy Expenditure</keyword>
  <keyword>Whole Body Vibration</keyword>
  <keyword>Exercise</keyword>
  <keyword>Blood Lactate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>If, and when requested, participants may review findings by contacting the PI. Other than participants, only investigators will have access to the data.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Blood Lactate Response in PD</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="P2">
          <title>Blood Lactate Response in MS</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="P3">
          <title>Blood Lactate Responses in Healthy, Older Adults</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Blood Lactate Response in PD</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="B2">
          <title>Blood Lactate Response in MS</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="B3">
          <title>Blood Lactate Responses in Healthy, Older Adults</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="9"/>
                    <measurement group_id="B2" value="52" spread="10"/>
                    <measurement group_id="B3" value="50" spread="10"/>
                    <measurement group_id="B4" value="59" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Lactate Response</title>
        <description>Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise</description>
        <time_frame>Before, immediately after, and 10 minutes after the squatting exercise protocol</time_frame>
        <population>2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.&#xD;
1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Lactate Response in PD</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O2">
            <title>Blood Lactate Response in MS</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O3">
            <title>Blood Lactate Responses in Healthy, Older Adults</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Lactate Response</title>
          <description>Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise</description>
          <population>2 of the 8 participants in the healthy, older adults group did not return for this visit, and thus, were not included in analysis.&#xD;
1 of the 12 MS participants did not return for this visit, and thus, were not included in analysis.</population>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre without Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="0.7"/>
                    <measurement group_id="O2" value="1.6" spread="0.7"/>
                    <measurement group_id="O3" value="1.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately Post without Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="0.9"/>
                    <measurement group_id="O2" value="2.8" spread="1.3"/>
                    <measurement group_id="O3" value="2.5" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Minutes Post without Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.3"/>
                    <measurement group_id="O2" value="3.3" spread="2.3"/>
                    <measurement group_id="O3" value="2.6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre with Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.7"/>
                    <measurement group_id="O2" value="2.2" spread="1.0"/>
                    <measurement group_id="O3" value="1.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately Post with Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.4"/>
                    <measurement group_id="O2" value="4.3" spread="3.0"/>
                    <measurement group_id="O3" value="2.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 Minutes Post with Whole Body Vibration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.5"/>
                    <measurement group_id="O2" value="3.1" spread="1.9"/>
                    <measurement group_id="O3" value="2.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Resting Energy Expenditure</title>
        <description>Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.</description>
        <time_frame>Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.</time_frame>
        <population>1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.&#xD;
1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results.</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Lactate Response in PD</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O2">
            <title>Blood Lactate Response in MS</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O3">
            <title>Blood Lactate Responses in Healthy, Older Adults</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
        </group_list>
        <measure>
          <title>Resting Energy Expenditure</title>
          <description>Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.</description>
          <population>1 of the 12 PD participants had severe claustrophobia, and could not tolerate the breathing mask on their face.&#xD;
1 of the 12 PD participants, and 1 of the 8 healthy, older adults participants: dysfunctional equipment, and thus invalid results.</population>
          <units>kcal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1338" spread="284"/>
                    <measurement group_id="O2" value="1262" spread="139"/>
                    <measurement group_id="O3" value="1521" spread="276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Neurological Function</title>
        <description>Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.</description>
        <time_frame>Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.</time_frame>
        <population>The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Lactate Response in PD</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O2">
            <title>Blood Lactate Response in MS</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O3">
            <title>Blood Lactate Responses in Healthy, Older Adults</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
        </group_list>
        <measure>
          <title>Neurological Function</title>
          <description>Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.</description>
          <population>The MS and healthy, older adults populations were not required to be assessed with the UPDRS because the assessment materials were for PD populations, specifically.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Health and Activity Questionnaire</title>
        <description>Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.&#xD;
Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.</description>
        <time_frame>Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.</time_frame>
        <population>2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Lactate Response in PD</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O2">
            <title>Blood Lactate Response in MS</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O3">
            <title>Blood Lactate Responses in Healthy, Older Adults</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
        </group_list>
        <measure>
          <title>Health and Activity Questionnaire</title>
          <description>Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.&#xD;
Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.</description>
          <population>2 of the 8 healthy, older adults did not complete all of the surveys, and were thus, clearly unable to be added to analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Funcitoning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" spread="21"/>
                    <measurement group_id="O2" value="66" spread="22"/>
                    <measurement group_id="O3" value="95" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Limitations due to Physical Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" spread="34"/>
                    <measurement group_id="O2" value="70" spread="32"/>
                    <measurement group_id="O3" value="82" spread="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Limitations due to Emotional Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="34"/>
                    <measurement group_id="O2" value="82" spread="26"/>
                    <measurement group_id="O3" value="90" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Energy/Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="17"/>
                    <measurement group_id="O2" value="42" spread="26"/>
                    <measurement group_id="O3" value="71" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Well-Being</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="16"/>
                    <measurement group_id="O2" value="75" spread="13"/>
                    <measurement group_id="O3" value="87" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="20"/>
                    <measurement group_id="O2" value="73" spread="22"/>
                    <measurement group_id="O3" value="95" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="16"/>
                    <measurement group_id="O2" value="70" spread="29"/>
                    <measurement group_id="O3" value="86" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" spread="19"/>
                    <measurement group_id="O2" value="58" spread="15"/>
                    <measurement group_id="O3" value="87" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activities of Daily Living</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="5"/>
                    <measurement group_id="O2" value="NA" spread="NA">Participants in this group did not complete this survey.</measurement>
                    <measurement group_id="O3" value="100" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Fatigue/Depression Assessment</title>
        <description>Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.&#xD;
Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.</description>
        <time_frame>Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.</time_frame>
        <population>2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Blood Lactate Response in PD</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O2">
            <title>Blood Lactate Response in MS</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
          <group group_id="O3">
            <title>Blood Lactate Responses in Healthy, Older Adults</title>
            <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
          </group>
        </group_list>
        <measure>
          <title>Fatigue/Depression Assessment</title>
          <description>Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.&#xD;
Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.</description>
          <population>2 of the 8 healthy, older adults did not complete all of the surveys, and were thus unable to be added to analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="5"/>
                    <measurement group_id="O2" value="8" spread="5"/>
                    <measurement group_id="O3" value="3" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" spread="18"/>
                    <measurement group_id="O2" value="38" spread="17"/>
                    <measurement group_id="O3" value="17" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the study collection period</time_frame>
      <desc>Subjects were asked about any adverse affects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Blood Lactate Response in PD</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="E2">
          <title>Blood Lactate Response in MS</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
        <group group_id="E3">
          <title>Blood Lactate Responses in Healthy, Older Adults</title>
          <description>This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.&#xD;
pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.&#xD;
Whole Body Vibration</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael J. Ormsbee</name_or_title>
      <organization>Florida State University</organization>
      <phone>6103313126</phone>
      <email>mormsbee@fsu.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02184494
org study id: 2014:12658
secondary id: HPN
nct id: NCT02184494
lead sponsor: 
has dmc: No
Fatigue is one of the most common and debilitating symptoms experienced in Parkinson's
      Disease (PD) and Multiple Sclerosis (MS). There are multiple proposed mechanisms of
      disorder-related fatigue, however, it is unknown whether PD or MS patients experience
      compromised blood lactate responses to an acute bout of exercise, subjecting them to
      exercise-related fatigue. These populations may experience higher energy expenditure at rest
      due to increased rigidity, however, limited data exists investigating resting energy
      expenditure in these populations.

      Researchers hypothesize that PD and MS patients will display higher resting energy
      expenditure than healthy age-matched controls, and that level of energy expenditure will
      correlate with amount of rigidity or spasticity. Also, we hypothesize that baseline levels of
      lactate will not be different between PD/MS and control groups, but post-exercise blood
      lactate levels will be significantly higher in the PD/MS groups.
Patients diagnosed with Parkinson's Disease (PD) and Multiple Sclerosis (MS) frequently
      experience increased levels of muscle weakness and fatigue; This impairment is exacerbated
      with onset of exercise and alleviated with rest or sleep . Importantly, in about 1/3 of PD
      patients, fatigue is considered debilitating , and even further, there is inconclusive
      evidence suggesting that anti-PD and anti-MS drugs improve fatigue. The precise mechanisms
      and pathogenesis of the disorder-specific fatigue in PD and MS remain elusive.

      Both peripheral and central cholinergic systems are affected in PD , however, it has been
      shown that peripheral cholinergic neurons at the neuromuscular junction are normal
      functioning . Even so, recruitment of necessary motor units may be greatly affected due to
      peripheral neuropathy common in both PD and MS . Following repetitive nerve stimulation in PD
      and MS, there is consistent evidence of a decrease in the number of functioning motor units
      and decrements in muscle responses. This promotes progressive fatigue with decrements in the
      amplitude of movement. Therefore, recruitment of motor units may be a major cause of rapid
      fatigue in repetitive movement with PD and MS patients, even though peripheral neuromuscular
      junctions do not seem to be affected. In addition to skeletal muscle inefficiency, work rate
      and efficiency of breathing using respiratory muscles is significantly lower in a PD
      population during repetitive stimulation, used to simulate exercise-induced repetitive
      contractions. Respiratory inefficiencies in MS include, but are not limited to reduced forced
      vital capacity, hypoxemia, and respiratory muscle weakness.

      In addition to possible neurological mechanisms of PD- and MS-related fatigue, rigidity,
      defined as involuntary state of continuous muscle tension in PD, and spasticity and rigidity
      in MS may also have a profound effect on fatigue outcomes . Adequate muscle length is
      required for effective muscle contraction. Rigidity likely changes the length of the muscle
      at rest, and therefore contributes to ineffective muscle contraction when active. In addition
      to inefficient muscle contraction, the increased continuous active contraction, or tone, of
      the muscle results in an increase in resting energy expenditure compared to healthy
      individuals, even in pharmacologically treated PD patients. Interestingly, resting energy
      expenditure in MS patients was shown to be comparable to age-matched healthy controls;
      however, it is important to note that these MS patients remained medicated during the study.
      In addition, rigidity and spasticity, common in PD and MS, respectively may provide varying
      levels of resting energy expenditure; however, no research to date has examined these
      differences. In total, if more energy is being expended at rest, hypothetically, PD and MS
      patients will have inadequate energy stores to exercise to their respective full capacity.
      This could potentiate early onset of lactic acid and hydrogen accumulation in active muscle,
      decrease the pH of the active muscle, and contribute to early fatigue in repetitive tasks.

      Purportedly, the combination of early onset of skeletal and respiratory muscle fatigue, in
      addition to muscle rigidity would create an environment similar to that of high intensity
      exercise, even at low intensities or rest. The ensuing result may likely be an accumulation
      of lactic acid and hydrogen ions, making the muscle environment very acidic. However, changes
      in the levels of resting and post-exercise blood lactate levels have not been elucidated.
      Therefore, we are planning to measure resting energy expenditure using a ventilation face
      mask and a noseclip. Blood lactate will be sampled at rest, after simulated high-intensity
      exercise, and ten minutes after rest (when lactate significantly increases). The exercise
      will consist of performing 5 sets of static, shallow 120 degree squats for 1 minute, with 1
      minute of seated rest between each squat. Sustained isometric contraction at 2/3 of the
      maximal voluntary contractile force for 2 to 3 minutes was found to occlude local blood flow
      enough that local oxygen stores were depleted . Muscle lactate is also increased 12-fold upon
      fatigue of isometric holds such as squats. This same environment of lactic acid buildup can
      be simulated by circulatory occlusion as well as 60-second isometric quadricep contractions .
      Isometric squats will be employed to observe differences in blood response in PD compared to
      healthy individuals.

      Therefore, the purpose of this study is to analyze the differences in resting energy
      expenditure and exercise-induced lactate production in PD and MS compared to healthy,
      age-matched controls.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood Lactate Response
time frame: Before, immediately after, and 10 minutes after the squatting exercise protocol
description: Measured using a blood lactate analyzer, a finger prick test measured before, after, and 10 minutes after exercise
measure: Resting Energy Expenditure
time frame: Measured immediately upon arriving to the laboratory. Lasted approximately 25 minutes.
description: Measured using using indirect calorimetry with a ventilated face mask and noseclip (Parvometrics, Sandy, UT). This involves laying supine for 30 to 60 minutes.
measure: Neurological Function
time frame: Measured immediately after the resting energy expenditure measurement, and before the other questionnaires. Lasted approximately 15 minutes.
description: Neurological functional state will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). Of the 5 sections of the examination, two parts were used. Part II (self-evaluation of aspects of the experiences of daily living) consisted of 13 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, saliva and drooling, chewing and swallowing, eating tasks, dressing, hygiene, handwriting, doing hobbies and other activities, turning in bed, tremor, getting out of bed/car/deep chair, walking and balance, and freezing. Part III (motor evaluation performed by trained research personnel) consisted of 14 Likert scale questions (graded 0 to 4, with 4 being most severe), including speech, facial expression, rigidity, finger tapping, hand movements, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, etc... Values were summed, with higher values indicating increased impairment and disability.
measure: Health and Activity Questionnaire
time frame: Collected immediately after the UPDRS (if PD population), or immediately after the resting energy expenditure measurement (if MS or healthy, older adult). Measured with other questionnaires and immediately before squatting exercise. Lasted ~10 minutes.
description: Short Form 36 Health Survey questionnaire: patient-reported survey of 36 questions, yielding the participant's degree of health on 8 different scale scores (each scale summed into a 0-100 score, with lower scores indicating more disability). The eight scales include vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health.
Schwab and England Activities of Daily Living Questionnaire: self-rated, single item assessment of the participant's ability to perform daily activities with speed and independence, measured using a Likert scale of percentages, in 10% increments. A score of 100% indicates total independence, while 0% indicates complete dependence.
measure: Fatigue/Depression Assessment
time frame: Collected at the same time as the other questionnaires. Lasted approximately 5-7 minutes.
description: Fatigue Severity Scale: 9-item, self-reporting rating that rates the severity of your fatigue symptoms on a Likert scale ranging from 1 to 7, with 1 indicating strong disagreement, and 7 indicating strong agreement. The sum of scores is calculated. The lower the score, the more severe the participant's fatigue symptoms.
Beck's Depression Inventory: 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression on a Likert scale ranging from 0 to 3, with 3 being the most severe. The sum of scores is calculated. A high score indicates more severe depression and related symptoms.
arm group label: Blood Lactate Response in PD
arm group type: Experimental
description: This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
arm group label: Blood Lactate Response in MS
arm group type: Experimental
description: This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
arm group label: Blood Lactate Responses in Controls
arm group type: Experimental
description: This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate (pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)), and one on the ground.
intervention type: Device
intervention name: pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)
description: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
Whole Body Vibration
arm group label: Blood Lactate Response in MS
arm group label: Blood Lactate Response in PD
arm group label: Blood Lactate Responses in Controls
criteria: 
gender: All
minimum age: 45 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael J Ormsbee, Ph.D.
role: Principal Investigator
affiliation: Florida State University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Michael J. Ormsbee
investigator title: Assistant Professor
mesh term: Parkinson Disease
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Yes
ipd description: If, and when requested, participants may review findings by contacting the PI. Other than participants, only investigators will have access to the data.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 