Spinal Cord InjuryCHOICESNCT01718977
Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)
A study testing Body Weight Supported Treadmill Training and Arm Cycle Ergometry Training in people with Spinal Cord Injury, run by University of British Columbia at 3 sites in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Body Weight Supported Treadmill Training and Arm Cycle Ergometry Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesCanada
- Study dates
- Jan 2013to 17 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age
- Motor-complete SCI (AIS A or B)
- Severe SCI (C4-T6)
- Individuals must be competent to give informed consent.
- cfPWV above median for age:
- < 30 years = 6.1 m/s
Show all 10Show fewer
- 30-39 years = 6.4 m/s
- 40-49 years = 6.9 m/s
- 50-59 years = 8.1 m/s
- ≥ 60 years = 9.7 m/s
Who cannot join
- History and/or symptoms of CVD or cardiopulmonary problems/disease.
- Major trauma or surgery within the last 6 months.
- Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
- Recent (within 1 year) history of lower-extremity or non-union fracture
- Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.
- Individuals with active medical issues such as pressure sores, urinary tract infections, hypertension, or heart disorders.
Show all 9Show fewer
- Any cognitive dysfunction or language barrier that would prevent subjects from following English instructions.
- Subjects may be excluded at the discretion of the principal investigator due to other, unforeseen, safety issues.
- Weighing >135 kg (absolute weight capacity of the body weight-supported treadmill).
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
McMaster University
Hamilton, Ontario, L8S 4L8
Toronto Rehabilitation Institute
Toronto, Ontario
International Collaboration On Repair Discoveries
Vancouver, British Columbia, V5Z 1M9
About this study
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.
Read the detailed description
- 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.
- 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).
- 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.
- 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.
- 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).
- Conditions
- Spinal Cord Injury
- Being tested
- Body Weight Supported Treadmill Training, Arm Cycle Ergometry Training
- Keywords
- Intervention, Body Weight Supported Treadmill Training, Arm Cycle Ergometry Training, carotid-to-femoral pulse wave velocity
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Weight Supported Treadmill TrainingOther
Also called BWSTT
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 Cycle Ergometry TrainingOther
Also called ACET
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.
| Study group | Role | What they receive |
|---|---|---|
| Body Weight Supported Treadmill Training | Experimental | 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. Receives: Other: Body Weight Supported Treadmill Training |
| Arm Cycle Ergometry Training | Active comparator | 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. Receives: Other: Arm Cycle Ergometry Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cfPWV assessed at baseline, 3- and 6-months.
Secondary outcomes (6)
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.
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.
Measured: Assessed at baseline, 3- and 6-months.
The effect of 6-months Body Weight Support Treadmill Training (BWSTT) on Autonomic function in people with Spinal Cord Injury (SCI).
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.
Measured: Assessed at baseline and 6-months.
The effect of Body Weight Support Treadmill Training (BWSTT) on Body Composition in people with Spinal Cord Injury (SCI) following 6-months of exercise.
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.
Measured: Assessed at baseline and 6-months.
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.
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.
Measured: Assessed at baseline and 6-months.
The effect of Body Weight Support Treadmill Training (BWSTT) on aerobic fitness in people with Spinal Cord Injury (SCI) following 6-months of exercise.
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.
Measured: Assessed at baseline and 6-months.
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).
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
Measured: Assessed at baseline, 3 months, 6 months and 12 months (6 months following either intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2013
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Toronto Rehabilitation Institute, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei V Krassiokov, M.D., PhD, Principal investigator, ICORD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718977
- Sponsor's protocol ID
- H12-02945
- Acronym
- CHOICES
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2012
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30612110Dorey TW, Nightingale TE, Alrashidi AA, Thomas S, Currie KD, Hubli M, Balthazaar SJT, Krassioukov AV. Effects of exercise on autonomic cardiovascular control in individuals with chronic, motor-complete spinal cord injury: an exploratory randomised clinical trial. Spinal Cord. 2024 Oct;62(10):597-604. doi: 10.1038/s41393-024-01019-z. Epub 2024 Aug 31.
PubMed 39217247Alrashidi AA, Nightingale TE, Currie KD, Hubli M, MacDonald MJ, Hicks AL, Oh P, Craven BC, Krassioukov AV. Exercise Improves Cardiorespiratory Fitness, but Not Arterial Health, after Spinal Cord Injury: The CHOICES Trial. J Neurotrauma. 2021 Nov 1;38(21):3020-3029. doi: 10.1089/neu.2021.0071. Epub 2021 Sep 3.
PubMed 34314235
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)
- ClinicalTrials.gov ID
- NCT01718977
- Acronym / sponsor ID
- CHOICES / H12-02945
- Conditions
- Spinal Cord Injury
- Keywords
- Intervention, Body Weight Supported Treadmill Training, Arm Cycle Ergometry Training, carotid-to-femoral pulse wave velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- McMaster University, Toronto Rehabilitation Institute, Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2013 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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).
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Weight Supported Treadmill Training | Experimental | Other: Body Weight Supported Treadmill TrainingBWSTT 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 Cycle Ergometry Training | Active comparator | Other: Arm Cycle Ergometry TrainingArm 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18-60 years of age
- Motor-complete SCI (AIS A or B)
- Severe SCI (C4-T6)
- Individuals must be competent to give informed consent.
- cfPWV above median for age:
Key exclusion criteria (9 listed)
- History and/or symptoms of CVD or cardiopulmonary problems/disease.
- Major trauma or surgery within the last 6 months.
- Active Stage 3 or 4 pressure ulcer (based on the National Pressure Ulcer Advisory Panel classification)
- Recent (within 1 year) history of lower-extremity or non-union fracture
- Any unstable medical/psychiatric condition or substance abuse disorder that is likely to affect their ability to complete this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Weight Supported Treadmill TrainingAlso: BWSTTBWSTT 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. | Other | Body Weight Supported Treadmill Training |
| Arm Cycle Ergometry TrainingAlso: ACETArm 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. | Other | Arm Cycle Ergometry Training |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Background: PubMed 30612110Krassioukov 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.
- Derived from this study: PubMed 39217247Dorey TW, Nightingale TE, Alrashidi AA, Thomas S, Currie KD, Hubli M, Balthazaar SJT, Krassioukov AV. Effects of exercise on autonomic cardiovascular control in individuals with chronic, motor-complete spinal cord injury: an exploratory randomised clinical trial. Spinal Cord. 2024 Oct;62(10):597-604. doi: 10.1038/s41393-024-01019-z. Epub 2024 Aug 31.
- Derived from this study: PubMed 34314235Alrashidi AA, Nightingale TE, Currie KD, Hubli M, MacDonald MJ, Hicks AL, Oh P, Craven BC, Krassioukov AV. Exercise Improves Cardiorespiratory Fitness, but Not Arterial Health, after Spinal Cord Injury: The CHOICES Trial. J Neurotrauma. 2021 Nov 1;38(21):3020-3029. doi: 10.1089/neu.2021.0071. Epub 2021 Sep 3.
- Trial ProtocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei V Krassiokov, M.D., PhD principal investigator
ICORD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body Weight Supported Treadmill Training and Arm Cycle Ergometry Training in people with Spinal Cord Injury, run by University of British Columbia at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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. (time frame: cfPWV assessed at baseline, 3- and 6-months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718977, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.