Cardiovascular Health/Outcomes: Improvements Created by Exercise and Education in SCI (CHOICES)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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).

      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: 
      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).
    

Intervention name(s): Body Weight Supported Treadmill Training; Arm Cycle Ergometry Training
Intervention type(s): Other; Other
Intervention description(s): 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 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 intervention name(s): BWSTT; ACET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Intervention; Body Weight Supported Treadmill Training; Arm Cycle Ergometry Training; carotid-to-femoral pulse wave velocity