Early exercise after spinal cord injury ('Switch-On'): study protocol for a randomised controlled trial

Area of Science:

• Neurology
• Rehabilitation Medicine
• Bone Biology

Background:

• Spinal cord injury (SCI) causes significant muscle atrophy, bone loss, and fragility.
• Early interventions to prevent these changes after SCI are not well-established.
• The impact of exercise on preventing early bone loss and microarchitectural decay post-SCI remains unclear.

Purpose of the Study:

• To determine if functional electrical stimulation (FES)-assisted cycling can prevent muscle atrophy and maintain skeletal integrity in individuals with acute spinal cord injury.
• To compare the effectiveness of FES-assisted cycling against passive cycling over a 12-week period.

Main Methods:

• A multi-centre, parallel-group, assessor-blinded randomized controlled trial involving 50 participants with acute SCI.
• Participants were randomized to either a 12-week FES-assisted cycling program or a 12-week passive cycling program.
• Primary outcome: muscle cross-sectional area via MRI; Secondary outcomes: bone biomarkers, immune markers, neurological function, body composition, depression, and quality of life.

Main Results:

• Data collection and analysis are ongoing.
• The study aims to provide definitive results on the efficacy of FES-assisted cycling.

Conclusions:

• The trial will elucidate the comparative efficacy of FES-assisted cycling versus passive cycling in mitigating muscle atrophy and preserving bone health following spinal cord injury.
• Findings will inform clinical practice and rehabilitation strategies for SCI patients.