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 · DOI: 10.1136/bmjopen-2018-023540 · Published: January 1, 2019

Spinal Cord Injury Cardiovascular Science Rehabilitation

Simple Explanation

This study aims to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level (above the sixth thoracic segment) SCI. Participants will be randomly assigned (1:1) into either ACET or BWSTT groups. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada. Participants in each group will exercise three times per week up to 30 min and 60 min for ACET and BWSTT, respectively, over the period of 6 months.

Study Duration

6 Months

Participants

60 participants with chronic (>1 year) SCI

Evidence Level

Randomised, controlled, clinical trial

Key Findings

1
The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline.
2
Secondary outcome measures will include comprehensive assessments of: (1) cardiovascular parameters, (2) autonomic function, (3) body composition, (4) blood haematological and metabolic profiles, (5) cardiorespiratory fitness and (6) quality of life (QOL) and physical activity outcomes.
3
In comparison with ACET, we hypothesise that, through large muscle mass involvement and postural challenge, the physical and metabolic stimuli of BWSTT will reduce cfPWV by 1 m/s in individuals with established risk (ie, cfPWV ≥ norm median value of age-matched able-bodied individuals at baseline).

Research Summary

This is a multicentre, randomised, controlled, clinical trial to compare the efficacy of arm cycle ergometry training (ACET) and body weight-supported treadmill training (BWSTT) on reducing arterial stiffness in individuals with chronic motor complete, high-level SCI. Sixty participants with chronic (>1 year) SCI will be recruited from three sites in Canada and randomly assigned to either ACET or BWSTT groups. The primary outcome measure will be change in arterial stiffness (cfPWV) from baseline. Secondary outcomes include cardiovascular parameters, autonomic function, body composition, blood profiles, cardiorespiratory fitness, and quality of life.

Practical Implications

Improved cardiovascular health

The study aims to determine whether BWSTT has beneficial effects, over and above ACET, on arterial stiffness and secondary health outcomes.

SCI-specific exercise guidelines

ACET prescribed at 3×30 min per week is in accordance with the updated SCI-specific exercise guidelines to achieve cardiometabolic health benefits and should reduce the risk of an overuse injury.

Clinical translation

The results of the CHOICES trial will be presented at national and international conferences and will be published in peer-reviewed journals.

Study Limitations

1
Lack of a follow-up time point for physiological outcomes to ascertain whether favourable adaptations persist beyond the intervention period
2
Lack of blinding (masking) of outcome assessors to intervention allocation.
3
Participants are somewhat homogeneous {ie, cervical and high thoracic motor complete spinal cord injury (SCI)}.

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