<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/NCT03793595</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-FY2019-34</org_study_id>
    <nct_id>NCT03793595</nct_id>
  </id_info>
  <brief_title>O2 Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus UE Arm Bike Test in Adults With SCI</brief_title>
  <official_title>Oxygen Consumption and Heart Rate Response to Battle Rope Exercise Protocol Versus Upper Extremity Arm Bike Test in Adults With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Woman's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Woman's University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel&#xD;
      seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in&#xD;
      subjects with spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Subjects will be scheduled for the first testing session after informed consent is&#xD;
           obtained.&#xD;
&#xD;
        2. Subjects will fill out PAR-Q+ to determine readiness for exercise testing&#xD;
&#xD;
        3. Subjects will fill out additional Questionnaire to determine exclusion based on medical&#xD;
           history&#xD;
&#xD;
        4. Prior to the physical performance tests, each participant will be fitted with a mask&#xD;
           that covers their face. This mask will be attached to a portable metabolic analyzer&#xD;
           (Cosmed k5b). This device collects the air expired which allows for energy expenditure&#xD;
           to be estimated.&#xD;
&#xD;
        5. Each participant will be fitted with the proper sized mask that is connected to a small&#xD;
           computer and power source supported at their upper back.&#xD;
&#xD;
        6. A polar heart rate strap monitor will be worn around the chest. As the participant&#xD;
           performs the physical performance tests, the Cosmed K5b measures the amount of carbon&#xD;
           dioxide and oxygen from each breath to estimate the amount of energy expended during&#xD;
           this task.&#xD;
&#xD;
      Session one:&#xD;
&#xD;
        1. Prior to beginning the testing, testing procedure will be explained to participants&#xD;
&#xD;
        2. Subjects blood pressure will be measured, and if a subject's average systolic or&#xD;
           diastolic blood pressure exceeds 140 or 90 mmHg, respectively, the subject will be asked&#xD;
           to return another day to perform the study procedures. If the blood pressure remains&#xD;
           elevated on either one of these measures, the subject will be excused from this study.&#xD;
&#xD;
        3. Subjects will then perform either the upper extremity cycling protocol or battle ropes&#xD;
           protocol first. The other will be performed on the subsequent testing date&#xD;
&#xD;
        4. If the subject is performing the upper extremity arm cycle test:&#xD;
&#xD;
           Each subject will perform a modified version of the ramped YMCA cycle test using a Upper&#xD;
           Extremity Cycle Ergometer and a portable metabolic cart&#xD;
&#xD;
             -  The ramped version of the YMCA cycle test will begin with the subject cycling at a&#xD;
                workload of 25 watts at a rate of 60 revolutions per minute (rpm) using a metronome&#xD;
                set at 120 beats per minute.&#xD;
&#xD;
             -  Each subject will pedal for 3-minute warm-up period at the 10 watts with the 60 rpm&#xD;
                rate. After the 3-minute warm-up, the workload will increase by 10 watts each&#xD;
                minute starting at 25 watts at pedal rate of 60 rpm until the subjects meets the&#xD;
                termination criteria as described below.&#xD;
&#xD;
        5. The portable metabolic cart is an instrument that measures levels of expired gases from&#xD;
           the subject as he or she exercises that will be analyzed and displayed on a computer&#xD;
           monitor. The subject will wear a face mask during the test. A Polar® heart rate monitor&#xD;
           will be worn on the chest, directly on the skin of each subject to obtain heart rate&#xD;
           measurements.&#xD;
&#xD;
        6. The goal is for the participant to perform the ramped exercise test using the protocol&#xD;
           described above and below until one or more of the following occurs, at which time the&#xD;
           test will be terminated: the participant requests the test to be stopped, a respiratory&#xD;
           exchange ratio of &gt;1.0 is achieved, or one of the following physiologic and/or&#xD;
           subjective signs/symptoms are present:&#xD;
&#xD;
             -  i. A drop in systolic blood pressure &gt;10 mmHg with the increasing work load&#xD;
&#xD;
             -  ii.An increase in systolic and/or diastolic blood pressure &gt;250 mmHg or 115 mmHg,&#xD;
                respectively.&#xD;
&#xD;
             -  iii.Reported chest or arm pain (angina)&#xD;
&#xD;
             -  iv.Severe shortness of breath, cyanosis, pallor, lightheadedness, dizziness or&#xD;
                confusion&#xD;
&#xD;
             -  v.No increase in heart rate despite increase in work load&#xD;
&#xD;
             -  vi.Complaints of severe fatigue&#xD;
&#xD;
             -  vii.The subject is unable to maintain a pedal rate of 50 rpm&#xD;
&#xD;
             -  viii.Borg 6-20 Perceived exertion scale score &gt;=20&#xD;
&#xD;
        7. The subjects heart rate will be recorded at the last 15-30 seconds of each minute during&#xD;
           the test.&#xD;
&#xD;
        8. Each subject's blood pressure will be taken before the test commences, every three&#xD;
           minutes during the test and once the test procedure is terminated.&#xD;
&#xD;
        9. The Borg 6-20 perceived exertion scale will be used to monitor the participant's rating&#xD;
           of perceived exertion every three minutes during the test. If at any time during the&#xD;
           test, the subject rates his or her perceived level of exertion at a level of 20, the&#xD;
           test will be terminated.&#xD;
&#xD;
       10. Session two: will occur at least three days after session one.&#xD;
&#xD;
       11. If the subject is performing the sitting battling rope:&#xD;
&#xD;
             -  a. A 10 to 15-minute demonstration will be provided to each subject on the proper&#xD;
                use of the battling ropes using the double arm swing technique&#xD;
&#xD;
             -  b. A 30 foot,1.5-inch diameter rope that will be anchored to a large weight&#xD;
&#xD;
                c. Each subject will position him/herself in their manual wheelchair with feet flat&#xD;
                on the floor or foot rests at shoulder width apart.&#xD;
&#xD;
             -  d. The subject's manual wheelchair will be secured using dumbbells and weights as&#xD;
                pictured below&#xD;
&#xD;
             -  e. A 3-minute warm up period will be given to each subject prior to the exercise&#xD;
                protocol&#xD;
&#xD;
                f. The subject will be fitted with a face mask attached to the metabolic cart as&#xD;
                described previously.&#xD;
&#xD;
                g. On command, each subject will begin swinging the rope as previously described in&#xD;
                the seated position using the double arm swing technique for 15 seconds at a&#xD;
                cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.&#xD;
&#xD;
                h. At each rest break, the subject will be asked to rate his/her levels of exertion&#xD;
                using the Borg 6-20 as described previously.&#xD;
&#xD;
             -  i. If a subject cannot complete the double arm rope swing at the required cadence&#xD;
                or if the rope does not undulate through the entire length of the rope towards the&#xD;
                anchor point, or if the subject requests to stop, the protocol will be terminated.&#xD;
&#xD;
       12. Reusable Mask cleaning procedure, performed following each participant&#xD;
&#xD;
             -  a. the following parts must be 1) rinsed with warm soapy water, 2) soaked in&#xD;
                CITADEX solution 15 minutes, 3) rinsed with cool running water again, 4) laid out&#xD;
                to dry:&#xD;
&#xD;
             -  b. Turbine (fan tube)&#xD;
&#xD;
             -  c. Flowmeter seal (black plastic cone ring)&#xD;
&#xD;
             -  d. Flowmeter cap (tan circle with black and silver emblem on it)&#xD;
&#xD;
             -  e. Face mask (blue plastic inserted vertically to avoid air pockets on interior)&#xD;
&#xD;
       13. After each use, the following parts must be wiped down with baby wipes and at the end of&#xD;
           the day must be soaked in soapy water for 10 minutes then wrung out and laid out to dry:&#xD;
&#xD;
             -  a. Head strap&#xD;
&#xD;
             -  b. Polar monitor strap&#xD;
&#xD;
             -  c. After each use, the following must be wiped with a disinfectant wipe:&#xD;
&#xD;
             -  d. Polar hear monitor&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)</measure>
    <time_frame>about 10-15 minutes after start of the protocol</time_frame>
    <description>VO2max will be measured using a portable metabolic cart (Cosmed k5b).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>about 10-15 minutes after start of the protocol</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of perceived exertion as assessed by the Borg 6-20 Perceived exertion scale</measure>
    <time_frame>about 10-15 minutes after start of the protocol</time_frame>
    <description>The Borg 6-20 Perceived exertion scale score ranges from 6-20, higher score indicates a worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>about 10-15 minutes after start of the protocol</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Spinal Cord Injury at T2 and Below</condition>
  <arm_group>
    <arm_group_label>Seated Battle Ropes Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Seated Upper Extremity Arm Bike</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seated Battle Ropes Protocol</intervention_name>
    <description>Participants will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.</description>
    <arm_group_label>Seated Battle Ropes Protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Seated Upper Extremity Arm Bike</intervention_name>
    <description>A modified Young Men's Christian Association (YMCA) cycle test will be performed.</description>
    <arm_group_label>Seated Upper Extremity Arm Bike</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spinal cord lesion T2 or below&#xD;
&#xD;
          -  Individuals with spinal cord injury for greater than six months&#xD;
&#xD;
          -  Utilize manual wheelchair for greater than 10 hours a day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current complaints of spinal, lower extremity or upper extremity pain or&#xD;
             musculoskeletal disorder that prevents the subject from performing repetitive upper&#xD;
             extremity cycling or grasping and swinging the weighted ropes against the floor&#xD;
&#xD;
          -  A current diagnosis of a chronic or acute cardiovascular, metabolic, renal or&#xD;
             pulmonary disease including use of a pacemaker&#xD;
&#xD;
          -  Anyone currently taking beta blocker medication&#xD;
&#xD;
          -  Anyone with blood pressure &gt;140/90 at the time of testing or with in the 2 weeks prior&#xD;
             to testing&#xD;
&#xD;
          -  Diagnosed sickle cell disease or sickle cell trait&#xD;
&#xD;
          -  Severe spasticity or joint contracture preventing subject from performing upper&#xD;
             extremity cycling or swinging of weighted ropes&#xD;
&#xD;
          -  Subjects with current decubital ulcers&#xD;
&#xD;
          -  History of autonomic dysreflexia in the last 6 months&#xD;
&#xD;
          -  Require physician follow-up prior to starting exercise based on PAR-Q+ questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wayne A Brewer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Woman's University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wayne A Brewer, PhD</last_name>
    <phone>713-794-2074</phone>
    <email>wbrewer@twu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Texas Woman's University</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wayne A Brewer, PhD</last_name>
      <phone>713-794-2074</phone>
      <email>wbrewer@twu.edu</email>
    </contact>
    <investigator>
      <last_name>Wayne Brewer, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 16, 2021</last_update_submitted>
  <last_update_submitted_qc>April 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Woman's University</investigator_affiliation>
    <investigator_full_name>Wayne Brewer</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03793595
org study id: IRB-FY2019-34
nct id: NCT03793595
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to compare energy expenditure and metabolic outcomes of a novel
      seated battle rope protocol to seated maximal ramped upper extremity ergometry protocol in
      subjects with spinal cord injury.
1. Subjects will be scheduled for the first testing session after informed consent is
           obtained.

        2. Subjects will fill out PAR-Q+ to determine readiness for exercise testing

        3. Subjects will fill out additional Questionnaire to determine exclusion based on medical
           history

        4. Prior to the physical performance tests, each participant will be fitted with a mask
           that covers their face. This mask will be attached to a portable metabolic analyzer
           (Cosmed k5b). This device collects the air expired which allows for energy expenditure
           to be estimated.

        5. Each participant will be fitted with the proper sized mask that is connected to a small
           computer and power source supported at their upper back.

        6. A polar heart rate strap monitor will be worn around the chest. As the participant
           performs the physical performance tests, the Cosmed K5b measures the amount of carbon
           dioxide and oxygen from each breath to estimate the amount of energy expended during
           this task.

      Session one:

        1. Prior to beginning the testing, testing procedure will be explained to participants

        2. Subjects blood pressure will be measured, and if a subject's average systolic or
           diastolic blood pressure exceeds 140 or 90 mmHg, respectively, the subject will be asked
           to return another day to perform the study procedures. If the blood pressure remains
           elevated on either one of these measures, the subject will be excused from this study.

        3. Subjects will then perform either the upper extremity cycling protocol or battle ropes
           protocol first. The other will be performed on the subsequent testing date

        4. If the subject is performing the upper extremity arm cycle test:

           Each subject will perform a modified version of the ramped YMCA cycle test using a Upper
           Extremity Cycle Ergometer and a portable metabolic cart

             -  The ramped version of the YMCA cycle test will begin with the subject cycling at a
                workload of 25 watts at a rate of 60 revolutions per minute (rpm) using a metronome
                set at 120 beats per minute.

             -  Each subject will pedal for 3-minute warm-up period at the 10 watts with the 60 rpm
                rate. After the 3-minute warm-up, the workload will increase by 10 watts each
                minute starting at 25 watts at pedal rate of 60 rpm until the subjects meets the
                termination criteria as described below.

        5. The portable metabolic cart is an instrument that measures levels of expired gases from
           the subject as he or she exercises that will be analyzed and displayed on a computer
           monitor. The subject will wear a face mask during the test. A Polar® heart rate monitor
           will be worn on the chest, directly on the skin of each subject to obtain heart rate
           measurements.

        6. The goal is for the participant to perform the ramped exercise test using the protocol
           described above and below until one or more of the following occurs, at which time the
           test will be terminated: the participant requests the test to be stopped, a respiratory
           exchange ratio of >1.0 is achieved, or one of the following physiologic and/or
           subjective signs/symptoms are present:

             -  i. A drop in systolic blood pressure >10 mmHg with the increasing work load

             -  ii.An increase in systolic and/or diastolic blood pressure >250 mmHg or 115 mmHg,
                respectively.

             -  iii.Reported chest or arm pain (angina)

             -  iv.Severe shortness of breath, cyanosis, pallor, lightheadedness, dizziness or
                confusion

             -  v.No increase in heart rate despite increase in work load

             -  vi.Complaints of severe fatigue

             -  vii.The subject is unable to maintain a pedal rate of 50 rpm

             -  viii.Borg 6-20 Perceived exertion scale score >=20

        7. The subjects heart rate will be recorded at the last 15-30 seconds of each minute during
           the test.

        8. Each subject's blood pressure will be taken before the test commences, every three
           minutes during the test and once the test procedure is terminated.

        9. The Borg 6-20 perceived exertion scale will be used to monitor the participant's rating
           of perceived exertion every three minutes during the test. If at any time during the
           test, the subject rates his or her perceived level of exertion at a level of 20, the
           test will be terminated.

       10. Session two: will occur at least three days after session one.

       11. If the subject is performing the sitting battling rope:

             -  a. A 10 to 15-minute demonstration will be provided to each subject on the proper
                use of the battling ropes using the double arm swing technique

             -  b. A 30 foot,1.5-inch diameter rope that will be anchored to a large weight

                c. Each subject will position him/herself in their manual wheelchair with feet flat
                on the floor or foot rests at shoulder width apart.

             -  d. The subject's manual wheelchair will be secured using dumbbells and weights as
                pictured below

             -  e. A 3-minute warm up period will be given to each subject prior to the exercise
                protocol

                f. The subject will be fitted with a face mask attached to the metabolic cart as
                described previously.

                g. On command, each subject will begin swinging the rope as previously described in
                the seated position using the double arm swing technique for 15 seconds at a
                cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.

                h. At each rest break, the subject will be asked to rate his/her levels of exertion
                using the Borg 6-20 as described previously.

             -  i. If a subject cannot complete the double arm rope swing at the required cadence
                or if the rope does not undulate through the entire length of the rope towards the
                anchor point, or if the subject requests to stop, the protocol will be terminated.

       12. Reusable Mask cleaning procedure, performed following each participant

             -  a. the following parts must be 1) rinsed with warm soapy water, 2) soaked in
                CITADEX solution 15 minutes, 3) rinsed with cool running water again, 4) laid out
                to dry:

             -  b. Turbine (fan tube)

             -  c. Flowmeter seal (black plastic cone ring)

             -  d. Flowmeter cap (tan circle with black and silver emblem on it)

             -  e. Face mask (blue plastic inserted vertically to avoid air pockets on interior)

       13. After each use, the following parts must be wiped down with baby wipes and at the end of
           the day must be soaked in soapy water for 10 minutes then wrung out and laid out to dry:

             -  a. Head strap

             -  b. Polar monitor strap

             -  c. After each use, the following must be wiped with a disinfectant wipe:

             -  d. Polar hear monitor
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cardiorespiratory fitness as assessed by maximum oxygen uptake (VO2max)
time frame: about 10-15 minutes after start of the protocol
description: VO2max will be measured using a portable metabolic cart (Cosmed k5b).
measure: Heart Rate
time frame: about 10-15 minutes after start of the protocol
measure: Rate of perceived exertion as assessed by the Borg 6-20 Perceived exertion scale
time frame: about 10-15 minutes after start of the protocol
description: The Borg 6-20 Perceived exertion scale score ranges from 6-20, higher score indicates a worse outcome.
measure: Blood pressure
time frame: about 10-15 minutes after start of the protocol
arm group label: Seated Battle Ropes Protocol
arm group type: Experimental
arm group label: Seated Upper Extremity Arm Bike
arm group type: Active Comparator
intervention type: Device
intervention name: Seated Battle Ropes Protocol
description: Participants will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.
arm group label: Seated Battle Ropes Protocol
intervention type: Device
intervention name: Seated Upper Extremity Arm Bike
description: A modified Young Men's Christian Association (YMCA) cycle test will be performed.
arm group label: Seated Upper Extremity Arm Bike
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wayne A Brewer, PhD
role: Principal Investigator
affiliation: Texas Woman's University
last name: Wayne A Brewer, PhD
phone: 713-794-2074
email: wbrewer@twu.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Woman's University
investigator full name: Wayne Brewer
investigator title: Associate Professor
mesh term: Spinal Cord Injuries
sharing ipd: No