<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/NCT02230267</url>
  </required_header>
  <id_info>
    <org_study_id>CTR-IN UNLVPT 2014.01</org_study_id>
    <nct_id>NCT02230267</nct_id>
  </id_info>
  <brief_title>High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease</brief_title>
  <official_title>High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several animal and human epidemiologic studies have provided evidence that exercise may be&#xD;
      neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the&#xD;
      case of those who have already been diagnosed with PD, it may slow the observed&#xD;
      neurodegeneration. Unfortunately, because this line of research is in early stages, there is&#xD;
      little evidence to indicate what biological mechanisms underlie the neuroprotection that is&#xD;
      conferred with exercise. Toward this end, it is possible that an interaction between&#xD;
      endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be&#xD;
      associated with exercise improvements in PD.&#xD;
&#xD;
      One of the most common reasons for premature death in PD is falls. Several meta-analyses have&#xD;
      concluded that exercise training programs focused on balance and/or strength training are&#xD;
      effective at improving aspects of balance. Taken together, the current body of evidence&#xD;
      suggests that exercise may be neuroprotective and balance/strength training may decrease the&#xD;
      likelihood of a fall. The combination of these efficacious treatment modalities (exercise and&#xD;
      balance/strength training) in a comprehensive treatment approach to improve PD symptoms and&#xD;
      balance has been previously reported at relatively mild or moderate exercise intensities.&#xD;
      Because recent research has suggested that patients with PD may benefit more from more&#xD;
      physically intense programs, we are proposing a more aggressive approach with regard to&#xD;
      exercise intensity and frequency in the present trial. The primary purpose of this study is&#xD;
      to determine the feasibility and safety of a high intensity exercise approach to PD. A&#xD;
      secondary purpose is to determine the trajectory of change in outcomes over the duration of&#xD;
      the trial from a high intensity fall prevention program. It is hoped that a signal of&#xD;
      efficacy will allow this trial to progress to a comparative effectiveness trial. An important&#xD;
      innovative design element is collecting biological assays to better understand the mechanism&#xD;
      underlying the anticipated clinical improvements.&#xD;
&#xD;
      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp&#xD;
      (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers&#xD;
      for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;&#xD;
      strengthening at least two times per week) for the duration of the trial. Aim 2 is to&#xD;
      determine if participation in an 8-week HIBC under the direction of a physical therapist is&#xD;
      safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week&#xD;
      HIBC will produce a signal of efficacy for several physical outcomes: falls per physical&#xD;
      activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,&#xD;
      cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an&#xD;
      8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory&#xD;
      cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF&#xD;
      val66val, val66met, met66met polymorphisms to determine if there is a differential response&#xD;
      to exercise.&#xD;
&#xD;
      This trial is innovative because it utilizes a high intensity comprehensive exercise&#xD;
      treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge,&#xD;
      there have been no trials of individuals with PD who have participated in a trial of this&#xD;
      intensity in a group &quot;boot camp&quot; setting. Another innovative design element is the use of&#xD;
      three novel assessments: biological assays of pro- and anti-inflammatory cytokines,&#xD;
      endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity&#xD;
      ratio).&#xD;
&#xD;
      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual&#xD;
      care control group (standard, low intensity group therapy class) under the direction of&#xD;
      physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist&#xD;
      ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required&#xD;
      to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise&#xD;
      components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of&#xD;
      strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes&#xD;
      of interspersed rest and stretching. Participants will rotate through these four exercise&#xD;
      components. Participants will have one baseline test and assessments at the 2-week, 4 week,&#xD;
      8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency&#xD;
      counts of participation, adverse events, and compliance with exercise. The outcomes for the&#xD;
      secondary aims will include measures of balance and falls, physical capacity, fatigue,&#xD;
      exercise/physical activity behavior, and biological assays.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency feasibility</measure>
    <time_frame>After completion of the 8 week trial</time_frame>
    <description>The number of participants that attend and participate in the treatment at least 3 times per week for 8 weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aerobic feasibility</measure>
    <time_frame>At the end of the 8 week trial</time_frame>
    <description>The number of participants that complete at least 150 minutes per week of moderate intensity exercise (70%+ of their estimated HR maximum). This will be ascertained using heart rate monitors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength feasibility</measure>
    <time_frame>At the end of the 8 week trial</time_frame>
    <description>The number of participants that participate in strengthening exercises that incorporates all the major muscle groups at least two days per week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance</measure>
    <time_frame>At the end of the 8 week trial</time_frame>
    <description>Drop-out rate and reason for drop-out will be tracked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>Ongoing throughout the 8 week trial</time_frame>
    <description>Exercise-related adverse events (e.g., strains/sprains, cardiovascular events).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Motivation</measure>
    <time_frame>At 8 weeks</time_frame>
    <description>The Intrinsic Motivation Inventory (IMI) will be used to gather information about motivation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Falls</measure>
    <time_frame>At the end of the 8 week trial</time_frame>
    <description>Falls and fall injuries in and out of boot camp will be collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Falls will be tracked for 6 months after the boot camp using a falls diary. A member of the research team will call each month to interview participants about their falls. We will assess falls/fall injuries per physical activity ratio during the 6 month period following the trial and time to a fall/fall injury after the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor activity</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Physical activity will be assessed using the Physical Activity Monitoring System (PAMsys).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Fatigue will be assessed using the Parkinson Fatigue Scale (PFS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>up to 6 months</time_frame>
    <description>This will be assessed functionally using the 30 second Sit-To-Stand Test (30STS) for muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognition</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>up to 6 months</time_frame>
    <description>This will be assessed by using a measure of disease-specific quality of life (Parkinson's Disease Questionnaire-39 (PDQ39)).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term behavioral change</measure>
    <time_frame>up to 6 months</time_frame>
    <description>All participants will track their participation in exercise and physical activity using an exercise diary for 6 months following the boot camp. Participants will be called monthly to reinforce completion of the exercise diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mini-Balance Evaluation Systems Test (mini-BESTest)</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Performance-based balance tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls self-efficacy</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Activities Specific Balance Confidence Scale (ABC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall Efficacy</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Self-report measurement tool: Falls Efficacy Scale (FES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall catastrophization</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Self-report of fall catastrophization: Catastrophization about Falls Questionnaire (CAFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Self-report measure physical activity: International Physical Activity Questionnaire (IPAQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor symptoms</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Unified Parkinson's Disease Rating Scale motor subscale (UDPRS III)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Self-report scale of avoidance behavior due to a fear of falling: Fear of Falls Avoidance Behavior Questionnaire (FFABQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Endurance will be assessed using the 6 Minute Walk Test (6MWT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone health</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Bone health will be measured using bone mineral densiometry (BMD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Mood will be measured using the Beck Depression Inventory.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catalase</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Catalase concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokines</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Cytokine (TNFα, IL-6, IL-10) concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BDNF</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Circulating BDNF concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>High intensity boot camp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each of the two HIBCs will have 10 participants (20 total) with a 1:5 physical therapist-to-patient ratio. Each HIBC session will last 1.5 hours and will be held on 4 days of the week. Participants will be required to attend 3 of those 4 days but may attend all. Because this is a pragmatic trial, therapists will have some leeway to control the intensity and the modality of the exercise. However, the basic format of the HIBC will consist of the following exercise components: A. 30 minutes of moderate-high intensity aerobic exercise at 70%+ of estimated maximum heart rate; B. 15 minutes of strengthening the major muscle groups of the trunk and upper/lower extremities; C. 15 minutes of balance training; and, D. 15 minutes of rest and stretching. Participants will rotate through these four different exercise components in a circuit fashion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The low intensity exercise group will participate in the Fitness Counts Exercise Program (FCEP) which is a basic low intensity, sitting and standing exercise program (10 minutes of stretching, 10 minutes of aerobic exercise (60% of heart rate maximum), and 10 minutes of strengthening). This exercise program was developed by the National Parkinson Foundation and is commonly used in PD exercise classes. The physical therapist-to-patient ratio will be 1:5. As there are two clinical sites, there will be 10 participants in each of the two boot camps (20 total). The FCEP will be 1 hour daily on four days of the week. Participants will be required to attend 3 days per week but may attend more if they are able.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High intensity exercise and balance training</intervention_name>
    <arm_group_label>High intensity boot camp</arm_group_label>
    <other_name>A. 30 minutes of moderate-high intensity aerobic exercise at 70%+ of estimated maximum heart rate</other_name>
    <other_name>B. 15 minutes of strengthening the major muscle groups of the trunk and upper/lower extremities</other_name>
    <other_name>C. 15 minutes of balance training</other_name>
    <other_name>D. 15 minutes of rest and stretching</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care arm exercise</intervention_name>
    <arm_group_label>Usual care arm</arm_group_label>
    <other_name>10 minutes of stretching</other_name>
    <other_name>10 minutes of aerobic exercise (60% of heart rate maximum)</other_name>
    <other_name>10 minutes of strengthening</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neurologist-diagnosed idiopathic PD based on the UK PD brain bank criteria&#xD;
&#xD;
          -  Aged 45-85&#xD;
&#xD;
          -  Hoehn and Yahr stages 1-3 (mild to moderate PD)&#xD;
&#xD;
          -  Participants do not anticipate a change in medication or surgical procedures in the&#xD;
             next 8 months of the trial (2 months for the trial and 6 for the follow-up)&#xD;
&#xD;
          -  Clearance from primary care physician to participate in the trial&#xD;
&#xD;
          -  Must be stable on PD medication and DBS for 3 months prior to trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poorly controlled or unstable cardiovascular disease that precludes participation in&#xD;
             exercise&#xD;
&#xD;
          -  Moderate-to-severe dementia using the Montreal Cognitive Assessment (MoCA). We will&#xD;
             exclude participants with a MoCA cut off score of &lt;26/30. This cut off value has&#xD;
             excellent sensitivity (90%) and specificity (75%).&#xD;
&#xD;
          -  Inability to stand or walk for more than 10 minutes&#xD;
&#xD;
          -  Other significant disorders that would limit endurance exercise participation (i.e.,&#xD;
             osteoarthritis, stroke, respiratory problems, traumatic brain injury, neuromuscular&#xD;
             disease, pain)&#xD;
&#xD;
          -  Already participating in a regular, vigorous exercise program (3X/week or more of &gt;60%&#xD;
             estimated maximum heart rate)&#xD;
&#xD;
          -  Participants will be excluded from the trial if they are taking any medications that&#xD;
             interfere with heart rate response to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Merrill Landers, PT, DPT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNLV</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nevada, Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Merrill Landers</investigator_full_name>
    <investigator_title>Chair and Associate Professor</investigator_title>
  </responsible_party>
  <keyword>boot camp</keyword>
  <keyword>exercise</keyword>
  <keyword>balance training</keyword>
  <keyword>fall prevention</keyword>
  <keyword>falling</keyword>
  <keyword>strength training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02230267
org study id: CTR-IN UNLVPT 2014.01
nct id: NCT02230267
lead sponsor: 
has dmc: No
Several animal and human epidemiologic studies have provided evidence that exercise may be
      neuroprotective in Parkinson's disease (PD). Exercise may forestall diagnosis and, in the
      case of those who have already been diagnosed with PD, it may slow the observed
      neurodegeneration. Unfortunately, because this line of research is in early stages, there is
      little evidence to indicate what biological mechanisms underlie the neuroprotection that is
      conferred with exercise. Toward this end, it is possible that an interaction between
      endogenous antioxidant enzymes, inflammatory processes, and reactive oxygen species may be
      associated with exercise improvements in PD.

      One of the most common reasons for premature death in PD is falls. Several meta-analyses have
      concluded that exercise training programs focused on balance and/or strength training are
      effective at improving aspects of balance. Taken together, the current body of evidence
      suggests that exercise may be neuroprotective and balance/strength training may decrease the
      likelihood of a fall. The combination of these efficacious treatment modalities (exercise and
      balance/strength training) in a comprehensive treatment approach to improve PD symptoms and
      balance has been previously reported at relatively mild or moderate exercise intensities.
      Because recent research has suggested that patients with PD may benefit more from more
      physically intense programs, we are proposing a more aggressive approach with regard to
      exercise intensity and frequency in the present trial. The primary purpose of this study is
      to determine the feasibility and safety of a high intensity exercise approach to PD. A
      secondary purpose is to determine the trajectory of change in outcomes over the duration of
      the trial from a high intensity fall prevention program. It is hoped that a signal of
      efficacy will allow this trial to progress to a comparative effectiveness trial. An important
      innovative design element is collecting biological assays to better understand the mechanism
      underlying the anticipated clinical improvements.

      Aim 1 is to test the feasibility of a high-intensity exercise and fall prevention boot camp
      (HIBC) in patients with PD by analyzing adherence and whether they achieve minimum Centers
      for Disease Control exercise standards (150 min/wk moderate level aerobic exercise;
      strengthening at least two times per week) for the duration of the trial. Aim 2 is to
      determine if participation in an 8-week HIBC under the direction of a physical therapist is
      safe for individuals with PD. Secondary Aim 3 is to determine if participation in an 8-week
      HIBC will produce a signal of efficacy for several physical outcomes: falls per physical
      activity ratio, balance efficacy, motor activity, fatigue, muscle strength, bone health,
      cognition/mood, and quality of life. Secondary Aim 4 is to determine if participation in an
      8-week HIBC will produce a signal of efficacy for biological outcomes, anti-inflammatory
      cytokines and anti-oxidant enzymes. An additional exploratory aim will be an analysis of BDNF
      val66val, val66met, met66met polymorphisms to determine if there is a differential response
      to exercise.

      This trial is innovative because it utilizes a high intensity comprehensive exercise
      treatment approach (aerobic exercise, strengthening, and balance training). To our knowledge,
      there have been no trials of individuals with PD who have participated in a trial of this
      intensity in a group "boot camp" setting. Another innovative design element is the use of
      three novel assessments: biological assays of pro- and anti-inflammatory cytokines,
      endogenous anti-oxidant enzymes and a novel assessment of falls (falls per physical activity
      ratio).

      Participants will be randomly assigned into either an 8-week HIBC group or an 8-week usual
      care control group (standard, low intensity group therapy class) under the direction of
      physical therapists. Each group will have 15 participants with a 1:5 patient-to-therapist
      ratio. The HIBC will be 1.5 hours daily, Monday through Friday. Participants will be required
      to attend 3 out of the 5 days. The protocol of the HIBC will include the following exercise
      components: A. 30 minutes of moderate-high intensity aerobic exercise; B. 15 minutes of
      strengthening the major muscle groups; C. 15 minutes of balance training; and, D. 15 minutes
      of interspersed rest and stretching. Participants will rotate through these four exercise
      components. Participants will have one baseline test and assessments at the 2-week, 4 week,
      8-week, and 6-month points. Outcomes of the primary aims (Aim 1 and Aim 2) will be frequency
      counts of participation, adverse events, and compliance with exercise. The outcomes for the
      secondary aims will include measures of balance and falls, physical capacity, fatigue,
      exercise/physical activity behavior, and biological assays.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Frequency feasibility
time frame: After completion of the 8 week trial
description: The number of participants that attend and participate in the treatment at least 3 times per week for 8 weeks.
measure: Aerobic feasibility
time frame: At the end of the 8 week trial
description: The number of participants that complete at least 150 minutes per week of moderate intensity exercise (70%+ of their estimated HR maximum). This will be ascertained using heart rate monitors.
measure: Strength feasibility
time frame: At the end of the 8 week trial
description: The number of participants that participate in strengthening exercises that incorporates all the major muscle groups at least two days per week.
measure: Compliance
time frame: At the end of the 8 week trial
description: Drop-out rate and reason for drop-out will be tracked.
measure: Safety
time frame: Ongoing throughout the 8 week trial
description: Exercise-related adverse events (e.g., strains/sprains, cardiovascular events).
measure: Motivation
time frame: At 8 weeks
description: The Intrinsic Motivation Inventory (IMI) will be used to gather information about motivation.
measure: Falls
time frame: At the end of the 8 week trial
description: Falls and fall injuries in and out of boot camp will be collected.
measure: Falls
time frame: up to 6 months
description: Falls will be tracked for 6 months after the boot camp using a falls diary. A member of the research team will call each month to interview participants about their falls. We will assess falls/fall injuries per physical activity ratio during the 6 month period following the trial and time to a fall/fall injury after the trial.
measure: Motor activity
time frame: up to 6 months
description: Physical activity will be assessed using the Physical Activity Monitoring System (PAMsys).
measure: Fatigue
time frame: up to 6 months
description: Fatigue will be assessed using the Parkinson Fatigue Scale (PFS).
measure: Strength
time frame: up to 6 months
description: This will be assessed functionally using the 30 second Sit-To-Stand Test (30STS) for muscle strength.
measure: Cognition
time frame: up to 6 months
description: Cognition will be assessed using the Montreal Cognitive Assessment (MoCA).
measure: Quality of life
time frame: up to 6 months
description: This will be assessed by using a measure of disease-specific quality of life (Parkinson's Disease Questionnaire-39 (PDQ39)).
measure: Long term behavioral change
time frame: up to 6 months
description: All participants will track their participation in exercise and physical activity using an exercise diary for 6 months following the boot camp. Participants will be called monthly to reinforce completion of the exercise diary.
measure: mini-Balance Evaluation Systems Test (mini-BESTest)
time frame: up to 6 months
description: Performance-based balance tasks.
measure: Falls self-efficacy
time frame: up to 6 months
description: Activities Specific Balance Confidence Scale (ABC)
measure: Fall Efficacy
time frame: Up to 6 months
description: Self-report measurement tool: Falls Efficacy Scale (FES)
measure: Fall catastrophization
time frame: Up to 6 months
description: Self-report of fall catastrophization: Catastrophization about Falls Questionnaire (CAFS)
measure: Physical activity
time frame: Up to 6 months
description: Self-report measure physical activity: International Physical Activity Questionnaire (IPAQ)
measure: Motor symptoms
time frame: Up to 6 months
description: Unified Parkinson's Disease Rating Scale motor subscale (UDPRS III)
measure: Fear of falling
time frame: Up to 6 months
description: Self-report scale of avoidance behavior due to a fear of falling: Fear of Falls Avoidance Behavior Questionnaire (FFABQ)
measure: Endurance
time frame: Up to 6 months
description: Endurance will be assessed using the 6 Minute Walk Test (6MWT).
measure: bone health
time frame: up to 6 months
description: Bone health will be measured using bone mineral densiometry (BMD).
measure: Mood
time frame: up to 6 months
description: Mood will be measured using the Beck Depression Inventory.
measure: Catalase
time frame: Up to 6 months
description: Catalase concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.
measure: Cytokines
time frame: Up to 6 months
description: Cytokine (TNFα, IL-6, IL-10) concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.
measure: BDNF
time frame: up to 6 months
description: Circulating BDNF concentrations from blood will be quantified utilizing enzyme-linked immunosorbent assays.
arm group label: High intensity boot camp
arm group type: Experimental
description: Each of the two HIBCs will have 10 participants (20 total) with a 1:5 physical therapist-to-patient ratio. Each HIBC session will last 1.5 hours and will be held on 4 days of the week. Participants will be required to attend 3 of those 4 days but may attend all. Because this is a pragmatic trial, therapists will have some leeway to control the intensity and the modality of the exercise. However, the basic format of the HIBC will consist of the following exercise components: A. 30 minutes of moderate-high intensity aerobic exercise at 70%+ of estimated maximum heart rate; B. 15 minutes of strengthening the major muscle groups of the trunk and upper/lower extremities; C. 15 minutes of balance training; and, D. 15 minutes of rest and stretching. Participants will rotate through these four different exercise components in a circuit fashion.
arm group label: Usual care arm
arm group type: Active Comparator
description: The low intensity exercise group will participate in the Fitness Counts Exercise Program (FCEP) which is a basic low intensity, sitting and standing exercise program (10 minutes of stretching, 10 minutes of aerobic exercise (60% of heart rate maximum), and 10 minutes of strengthening). This exercise program was developed by the National Parkinson Foundation and is commonly used in PD exercise classes. The physical therapist-to-patient ratio will be 1:5. As there are two clinical sites, there will be 10 participants in each of the two boot camps (20 total). The FCEP will be 1 hour daily on four days of the week. Participants will be required to attend 3 days per week but may attend more if they are able.
intervention type: Other
intervention name: High intensity exercise and balance training
arm group label: High intensity boot camp
other name: A. 30 minutes of moderate-high intensity aerobic exercise at 70%+ of estimated maximum heart rate
other name: B. 15 minutes of strengthening the major muscle groups of the trunk and upper/lower extremities
other name: C. 15 minutes of balance training
other name: D. 15 minutes of rest and stretching
intervention type: Other
intervention name: Usual care arm exercise
arm group label: Usual care arm
other name: 10 minutes of stretching
other name: 10 minutes of aerobic exercise (60% of heart rate maximum)
other name: 10 minutes of strengthening
criteria: 
gender: All
minimum age: 45 Years
maximum age: 85 Years
healthy volunteers: No
last name: Merrill Landers, PT, DPT, PhD
role: Principal Investigator
affiliation: UNLV
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Merrill Landers
investigator title: Chair and Associate Professor
mesh term: Parkinson Disease