<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/NCT01718977</url>
  </required_header>
  <id_info>
    <org_study_id>H12-02945</org_study_id>
    <nct_id>NCT01718977</nct_id>
  </id_info>
  <brief_title>Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)</brief_title>
  <acronym>CHOICES</acronym>
  <official_title>Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto Rehabilitation Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine whether body weight-supported treadmill training (BWSTT) has&#xD;
      beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of&#xD;
      cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).&#xD;
&#xD;
      After SCI, the primary cause of illness and death is CVD. Currently, preventative measures&#xD;
      focus around increasing physical activity- especially through the use of ACET. However,&#xD;
      ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated&#xD;
      that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular&#xD;
      health in individuals with SCI.&#xD;
&#xD;
      The studies primary outcome measure is carotid-to-femoral pulse wave velocity (cfPWV) which&#xD;
      has been shown to have prognostic value for CVD above and beyond that of other risk factors.&#xD;
      It is hypothesised that through large muscle mass involvement and postural challenge, the&#xD;
      physical stimuli of BWSTT will reduce cfPWV and lower CVD risk in individuals with SCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Purpose To determine whether body weight-supported treadmill training (BWSTT) has&#xD;
           beneficial effects, over and above arm-cycle ergometry training (ACET), on arterial&#xD;
           stiffness (carotid-to-femoral pulse wave velocity, cfPWV) and secondary health outcomes&#xD;
           (cardiovascular, autonomic and metabolic indices, fitness, body composition, and quality&#xD;
           of life) in individuals with chronic (≥ 1 year post-injury) motor-complete cervical and&#xD;
           high-thoracic SCI.&#xD;
&#xD;
        2. Hypothesis Through large muscle mass involvement and postural challenge, the physical&#xD;
           and metabolic stimuli of BWSTT will reduce carotid-to-femoral pulse wave velocity&#xD;
           (cfPWV) by 1 m/s in individuals with established risk (i.e. cfPWV ≥ norm median value of&#xD;
           age-matched able-bodied individuals).&#xD;
&#xD;
        3. Justification for the study Cardiovascular disease (CVD) is a leading cause of morbidity&#xD;
           and mortality in the SCI population. It is most commonly attributed to decreased&#xD;
           physical activity levels; therefore strategies for decreasing CVD risk are centred on&#xD;
           increasing physical activity. Unfortunately, the exercise-training literature in&#xD;
           populations with SCI is limited, making it difficult to design evidence-based exercise&#xD;
           prescriptions. ACET is widely used by individuals with SCI, but there is limited&#xD;
           evidence on its ability to improve cardiovascular health. Given the evidence linking&#xD;
           cardiovascular measures, specifically cfPWV, and CVD risk, an exercise prescription,&#xD;
           which is capable of eliciting both acute cardiovascular responses and chronic&#xD;
           cardiovascular adaptations, is crucial. BWSTT has demonstrated favorable cardiovascular&#xD;
           adaptations, but is primarily employed in individuals with incomplete SCI due to the&#xD;
           nature of the exercise. While preliminary evidence in individuals with complete SCI&#xD;
           suggest it may have favorable training effects, its effectiveness in a large sample of&#xD;
           individuals with chronic, motor-complete, severe SCI has yet to be established.&#xD;
&#xD;
        4. Objectives Cardiovascular adaptations in individuals with SCI predispose them to complex&#xD;
           secondary health problems. This study will use a comprehensive assessment of&#xD;
           cardiovascular risk factors and two different exercise interventions to assist in&#xD;
           developing cardiovascular risk profiles and determining if BWSTT has greater efficacy&#xD;
           than traditional exercise interventions (ACET) for decreasing cardiovascular risk in&#xD;
           individuals with high, severe SCI.&#xD;
&#xD;
        5. Research Method This study will employ a prospective, multi-centre, randomized,&#xD;
           controlled, single-blinded clinical trial. A total of 60 participants (20 per site)&#xD;
           between 18-60 years of age who have sustained a motor-complete (i.e., C4-T6, AIS A or B)&#xD;
           traumatic SCI ≥ 1 year prior will be recruited. Only individuals with cfPWV ≥ norm&#xD;
           median value of age-matched able-bodied individuals will be eligible to participate. The&#xD;
           primary outcome measure (cfPWV), and secondary cardiovascular and autonomic parameters&#xD;
           will be assessed using a combination of electrocardiography, ultrasound, blood pressure,&#xD;
           and applanation tonometry techniques. Fitness will be determined using a peak oxygen&#xD;
           consumption test on a arm-cycle ergometer. Body composition will be determined using a&#xD;
           dual energy x-ray absorbitrometry (DXA) scan. Metabolic indices will be determined from&#xD;
           blood sampling. Lastly, quality of life and physical activity levels will be assessed&#xD;
           using questionnaires. Measurements will take place at baseline (via participation in&#xD;
           Study 1), and 3 and 6-months of exercise training. Training will involve 3, 30 - 60&#xD;
           minute exercise sessions per week, for 24 weeks. Both BWSTT and ACET sessions will take&#xD;
           place at the Blusson Spinal Cord Centre at International Collaboration On Repair&#xD;
           Discoveries (ICORD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2013</start_date>
  <completion_date type="Actual">October 17, 2019</completion_date>
  <primary_completion_date type="Actual">October 17, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on carotid-to-femoral pulse wave velocity (cfPWV) in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise.</measure>
    <time_frame>cfPWV assessed at baseline, 3- and 6-months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on Cardiovascular parameters in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise.</measure>
    <time_frame>Assessed at baseline, 3- and 6-months.</time_frame>
    <description>Assessments of Blood Pressure &amp; Heart Rate, Arterial Structure, Cardiac Structure &amp; Function, Orthostatic Instability(Sit-Up Test) and 24-hr Blood Pressure Lability will be used to assess cardiovascular function.&#xD;
Parameters recorded from these tests include End Systolic Volume, End Diastolic Volume, Intraventricular Septum Systole (IVSs), Intraventricular Septum Diastole (IVSd), Left Ventricular Internal Diameter Systole (LVIDs), Left Ventricular Posterior Wall Systole (LVIDd), Left Ventricular Posterior Wall Diastole (LVPWd), Ejection Fraction, Cardiac Output, Fractional Shortening, Mitral Regurgitation (dP/dT), E/A, E/e' ratio, IVRT, DT, Lumen Diameter, Intima-Media Thickness, Wall/Lumen Ratio (Carotid, Brachial &amp; Femoral), Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Blood Pressure and Heart Rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of 6-months Body Weight Support Treadmill Training (BWSTT) on Autonomic function in people with Spinal Cord Injury (SCI).</measure>
    <time_frame>Assessed at baseline and 6-months.</time_frame>
    <description>Systolic and diastolic blood pressure, Mean Arterial Blood Pressure and Heart Rate will be measured. This outcome measure will also be assessed using the International Autonomic Standards Evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on Body Composition in people with Spinal Cord Injury (SCI) following 6-months of exercise.</measure>
    <time_frame>Assessed at baseline and 6-months.</time_frame>
    <description>Body composition will be assessed using Dual Energy X-Ray Absorptiometry (DXA). DXA will be used to assess Height, Total Body Fat (Kg), Lean Mass (Kg), Body Fat Percentage and Bone Mineral Density. Weight, body mass index (BMI), Waist and Hip Circumferences will also be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on Metabolic and hematological parameters in people with Spinal Cord Injury (SCI) following 6-months of exercise.</measure>
    <time_frame>Assessed at baseline and 6-months.</time_frame>
    <description>Metabolic parameters will be assessed through blood analysis. Blood analysis will yield the following metabolic and hematological parameters: White Blood Cell Count, Erythrocytes, Packed Cell Volume, Hematocrit, Platelets, Hemoglobin, Red Cell Indices, glycated hemoglobin (HbA1C), Fasting Glucose, Triglycerides, Total Cholesterol, LDL-C, HDL-C, TC/HDL-C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on aerobic fitness in people with Spinal Cord Injury (SCI) following 6-months of exercise.</measure>
    <time_frame>Assessed at baseline and 6-months.</time_frame>
    <description>Aerobic fitness will be assessed via a VO2 Peak tests completed on an arm cycle ergometer. We will record Resting ECG, Blood Pressure, RPE, Oxygen Consumption and VO2Peak as well as feedback from the Positive and Negative Affect Scale (PANAS) and Visual Analogue Pain Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of Body Weight Support Treadmill Training (BWSTT) on quality of life in people with Spinal Cord Injury (SCI) at 3 months, 6 months and 12 months (6-month follow-up after the exercise intervention).</measure>
    <time_frame>Assessed at baseline, 3 months, 6 months and 12 months (6 months following either intervention)</time_frame>
    <description>Quality of life (QoL) will be assessed through questionnaires administered centrally by Dr. Kathleen Martin-Ginis of McMaster University in Hamilton, Ontario.&#xD;
Questionnaires used to assess QoL are; Leisure-Time Physical Activity, Questionnaire for People with SCI, MOS-36 Pain and Health Subscales, Autonomic Questionnaire, Satisfaction with Life Scale, Life Satisfaction Questionnaire, Self-Efficacy for Aerobic Exercise, Spinal Cord Independence Measure, Impact on Participation and Autonomy Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Body Weight Supported Treadmill Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Cycle Ergometry Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.&#xD;
The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Body Weight Supported Treadmill Training</intervention_name>
    <description>BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.</description>
    <arm_group_label>Body Weight Supported Treadmill Training</arm_group_label>
    <other_name>BWSTT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm Cycle Ergometry Training</intervention_name>
    <description>Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.&#xD;
The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.</description>
    <arm_group_label>Arm Cycle Ergometry Training</arm_group_label>
    <other_name>ACET</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-60 years of age&#xD;
&#xD;
          -  Motor-complete SCI (AIS A or B)&#xD;
&#xD;
          -  Severe SCI (C4-T6)&#xD;
&#xD;
          -  Individuals must be competent to give informed consent.&#xD;
&#xD;
          -  cfPWV above median for age:&#xD;
&#xD;
               1. &lt; 30 years = 6.1 m/s&#xD;
&#xD;
               2. 30-39 years = 6.4 m/s&#xD;
&#xD;
               3. 40-49 years = 6.9 m/s&#xD;
&#xD;
               4. 50-59 years = 8.1 m/s&#xD;
&#xD;
               5. ≥ 60 years = 9.7 m/s&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History and/or symptoms of CVD or cardiopulmonary problems/disease.&#xD;
&#xD;
          -  Major trauma or surgery within the last 6 months.&#xD;
&#xD;
          -  Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory&#xD;
             Panel classification)&#xD;
&#xD;
          -  Recent (within 1 year) history of lower-extremity or non-union fracture&#xD;
&#xD;
          -  Any unstable medical/psychiatric condition or substance abuse disorder that is likely&#xD;
             to affect their ability to complete this study.&#xD;
&#xD;
          -  Individuals with active medical issues such as pressure sores, urinary tract&#xD;
             infections, hypertension, or heart disorders.&#xD;
&#xD;
          -  Any cognitive dysfunction or language barrier that would prevent subjects from&#xD;
             following English instructions.&#xD;
&#xD;
          -  Subjects may be excluded at the discretion of the principal investigator due to other,&#xD;
             unforeseen, safety issues.&#xD;
&#xD;
          -  Weighing &gt;135 kg (absolute weight capacity of the body weight-supported treadmill).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrei V Krassiokov, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICORD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Collaboration On Repair Discoveries</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 4L8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Rehabilitation Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326283/</url>
    <description>Trial Protocol</description>
  </link>
  <reference>
    <citation>Krassioukov AV, Currie KD, Hubli M, Nightingale TE, Alrashidi AA, Ramer L, Eng JJ, Ginis KAM, MacDonald MJ, Hicks A, Ditor D, Oh P, Verrier MC, Craven BC. Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]. BMJ Open. 2019 Jan 4;9(1):e023540. doi: 10.1136/bmjopen-2018-023540.</citation>
    <PMID>30612110</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Andrei Krassioukov</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Intervention</keyword>
  <keyword>Body Weight Supported Treadmill Training</keyword>
  <keyword>Arm Cycle Ergometry Training</keyword>
  <keyword>carotid-to-femoral pulse wave velocity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</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/NCT01718977
org study id: H12-02945
nct id: NCT01718977
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study aims to determine whether body weight-supported treadmill training (BWSTT) has
      beneficial effects, over and above arm-cycle ergometry training (ACET) on indicators of
      cardiovascular disease (CVD) risk in individuals with severe spinal cord injury (SCI).

      After SCI, the primary cause of illness and death is CVD. Currently, preventative measures
      focus around increasing physical activity- especially through the use of ACET. However,
      ACET's capacity to improve cardiovascular health is questionable. Research has demonstrated
      that BWSTT, an alternative form of exercise, may be capable of improving cardiovascular
      health in individuals with SCI.

      The studies primary outcome measure is carotid-to-femoral pulse wave velocity (cfPWV) which
      has been shown to have prognostic value for CVD above and beyond that of other risk factors.
      It is hypothesised that through large muscle mass involvement and postural challenge, the
      physical stimuli of BWSTT will reduce cfPWV and lower CVD risk in individuals with SCI.
1. Purpose To determine whether body weight-supported treadmill training (BWSTT) has
           beneficial effects, over and above arm-cycle ergometry training (ACET), on arterial
           stiffness (carotid-to-femoral pulse wave velocity, cfPWV) and secondary health outcomes
           (cardiovascular, autonomic and metabolic indices, fitness, body composition, and quality
           of life) in individuals with chronic (≥ 1 year post-injury) motor-complete cervical and
           high-thoracic SCI.

        2. Hypothesis Through large muscle mass involvement and postural challenge, the physical
           and metabolic stimuli of BWSTT will reduce carotid-to-femoral pulse wave velocity
           (cfPWV) by 1 m/s in individuals with established risk (i.e. cfPWV ≥ norm median value of
           age-matched able-bodied individuals).

        3. Justification for the study Cardiovascular disease (CVD) is a leading cause of morbidity
           and mortality in the SCI population. It is most commonly attributed to decreased
           physical activity levels; therefore strategies for decreasing CVD risk are centred on
           increasing physical activity. Unfortunately, the exercise-training literature in
           populations with SCI is limited, making it difficult to design evidence-based exercise
           prescriptions. ACET is widely used by individuals with SCI, but there is limited
           evidence on its ability to improve cardiovascular health. Given the evidence linking
           cardiovascular measures, specifically cfPWV, and CVD risk, an exercise prescription,
           which is capable of eliciting both acute cardiovascular responses and chronic
           cardiovascular adaptations, is crucial. BWSTT has demonstrated favorable cardiovascular
           adaptations, but is primarily employed in individuals with incomplete SCI due to the
           nature of the exercise. While preliminary evidence in individuals with complete SCI
           suggest it may have favorable training effects, its effectiveness in a large sample of
           individuals with chronic, motor-complete, severe SCI has yet to be established.

        4. Objectives Cardiovascular adaptations in individuals with SCI predispose them to complex
           secondary health problems. This study will use a comprehensive assessment of
           cardiovascular risk factors and two different exercise interventions to assist in
           developing cardiovascular risk profiles and determining if BWSTT has greater efficacy
           than traditional exercise interventions (ACET) for decreasing cardiovascular risk in
           individuals with high, severe SCI.

        5. Research Method This study will employ a prospective, multi-centre, randomized,
           controlled, single-blinded clinical trial. A total of 60 participants (20 per site)
           between 18-60 years of age who have sustained a motor-complete (i.e., C4-T6, AIS A or B)
           traumatic SCI ≥ 1 year prior will be recruited. Only individuals with cfPWV ≥ norm
           median value of age-matched able-bodied individuals will be eligible to participate. The
           primary outcome measure (cfPWV), and secondary cardiovascular and autonomic parameters
           will be assessed using a combination of electrocardiography, ultrasound, blood pressure,
           and applanation tonometry techniques. Fitness will be determined using a peak oxygen
           consumption test on a arm-cycle ergometer. Body composition will be determined using a
           dual energy x-ray absorbitrometry (DXA) scan. Metabolic indices will be determined from
           blood sampling. Lastly, quality of life and physical activity levels will be assessed
           using questionnaires. Measurements will take place at baseline (via participation in
           Study 1), and 3 and 6-months of exercise training. Training will involve 3, 30 - 60
           minute exercise sessions per week, for 24 weeks. Both BWSTT and ACET sessions will take
           place at the Blusson Spinal Cord Centre at International Collaboration On Repair
           Discoveries (ICORD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on carotid-to-femoral pulse wave velocity (cfPWV) in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise.
time frame: cfPWV assessed at baseline, 3- and 6-months.
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on Cardiovascular parameters in people with Spinal Cord Injury (SCI) at 3- and 6-months of exercise.
time frame: Assessed at baseline, 3- and 6-months.
description: Assessments of Blood Pressure & Heart Rate, Arterial Structure, Cardiac Structure & Function, Orthostatic Instability(Sit-Up Test) and 24-hr Blood Pressure Lability will be used to assess cardiovascular function.
Parameters recorded from these tests include End Systolic Volume, End Diastolic Volume, Intraventricular Septum Systole (IVSs), Intraventricular Septum Diastole (IVSd), Left Ventricular Internal Diameter Systole (LVIDs), Left Ventricular Posterior Wall Systole (LVIDd), Left Ventricular Posterior Wall Diastole (LVPWd), Ejection Fraction, Cardiac Output, Fractional Shortening, Mitral Regurgitation (dP/dT), E/A, E/e' ratio, IVRT, DT, Lumen Diameter, Intima-Media Thickness, Wall/Lumen Ratio (Carotid, Brachial & Femoral), Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Blood Pressure and Heart Rate.
measure: The effect of 6-months Body Weight Support Treadmill Training (BWSTT) on Autonomic function in people with Spinal Cord Injury (SCI).
time frame: Assessed at baseline and 6-months.
description: Systolic and diastolic blood pressure, Mean Arterial Blood Pressure and Heart Rate will be measured. This outcome measure will also be assessed using the International Autonomic Standards Evaluation.
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on Body Composition in people with Spinal Cord Injury (SCI) following 6-months of exercise.
time frame: Assessed at baseline and 6-months.
description: Body composition will be assessed using Dual Energy X-Ray Absorptiometry (DXA). DXA will be used to assess Height, Total Body Fat (Kg), Lean Mass (Kg), Body Fat Percentage and Bone Mineral Density. Weight, body mass index (BMI), Waist and Hip Circumferences will also be measured.
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on Metabolic and hematological parameters in people with Spinal Cord Injury (SCI) following 6-months of exercise.
time frame: Assessed at baseline and 6-months.
description: Metabolic parameters will be assessed through blood analysis. Blood analysis will yield the following metabolic and hematological parameters: White Blood Cell Count, Erythrocytes, Packed Cell Volume, Hematocrit, Platelets, Hemoglobin, Red Cell Indices, glycated hemoglobin (HbA1C), Fasting Glucose, Triglycerides, Total Cholesterol, LDL-C, HDL-C, TC/HDL-C.
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on aerobic fitness in people with Spinal Cord Injury (SCI) following 6-months of exercise.
time frame: Assessed at baseline and 6-months.
description: Aerobic fitness will be assessed via a VO2 Peak tests completed on an arm cycle ergometer. We will record Resting ECG, Blood Pressure, RPE, Oxygen Consumption and VO2Peak as well as feedback from the Positive and Negative Affect Scale (PANAS) and Visual Analogue Pain Scale.
measure: The effect of Body Weight Support Treadmill Training (BWSTT) on quality of life in people with Spinal Cord Injury (SCI) at 3 months, 6 months and 12 months (6-month follow-up after the exercise intervention).
time frame: Assessed at baseline, 3 months, 6 months and 12 months (6 months following either intervention)
description: Quality of life (QoL) will be assessed through questionnaires administered centrally by Dr. Kathleen Martin-Ginis of McMaster University in Hamilton, Ontario.
Questionnaires used to assess QoL are; Leisure-Time Physical Activity, Questionnaire for People with SCI, MOS-36 Pain and Health Subscales, Autonomic Questionnaire, Satisfaction with Life Scale, Life Satisfaction Questionnaire, Self-Efficacy for Aerobic Exercise, Spinal Cord Independence Measure, Impact on Participation and Autonomy Questionnaire
arm group label: Body Weight Supported Treadmill Training
arm group type: Experimental
description: BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.
arm group label: Arm Cycle Ergometry Training
arm group type: Active Comparator
description: Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.
The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.
intervention type: Other
intervention name: Body Weight Supported Treadmill Training
description: BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.
arm group label: Body Weight Supported Treadmill Training
other name: BWSTT
intervention type: Other
intervention name: Arm Cycle Ergometry Training
description: Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.
The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session.
arm group label: Arm Cycle Ergometry Training
other name: ACET
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Andrei V Krassiokov, M.D., PhD
role: Principal Investigator
affiliation: ICORD
facility: 
facility: 
facility: 
country: Canada
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326283/
description: Trial Protocol
citation: Krassioukov AV, Currie KD, Hubli M, Nightingale TE, Alrashidi AA, Ramer L, Eng JJ, Ginis KAM, MacDonald MJ, Hicks A, Ditor D, Oh P, Verrier MC, Craven BC. Effects of exercise interventions on cardiovascular health in individuals with chronic, motor complete spinal cord injury: protocol for a randomised controlled trial [Cardiovascular Health/Outcomes: Improvements Created by Exercise and education in SCI (CHOICES) Study]. BMJ Open. 2019 Jan 4;9(1):e023540. doi: 10.1136/bmjopen-2018-023540.
PMID: 30612110
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Andrei Krassioukov
investigator title: Principal Investigator
mesh term: Spinal Cord Injuries