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

Trials, 2015 · DOI: 10.1186/1745-6215-16-7 · Published: January 7, 2015

Simple Explanation

Spinal cord injury (SCI) leads to muscle atrophy and bone loss. This study investigates if early exercise can prevent these changes. Participants with acute SCI will be assigned to either FES-assisted cycling or passive cycling for 12 weeks to determine which is more effective. The study will measure muscle size, bone health markers, immune function, neurological function, body composition, depression, and quality of life.

Study Duration

12 weeks

Participants

50 participants with acute spinal cord injury

Evidence Level

Level 1: Multi-centre, parallel group, assessor-blinded randomised controlled trial

Key Findings

1
The trial aims to determine the effectiveness of FES-assisted cycling versus passive cycling in preventing muscle atrophy after spinal cord injury.
2
The study hypothesizes that muscle activation through FES-cycling will prevent muscle atrophy and preserve skeletal structure.
3
The primary outcome is muscle cross-sectional area of the thigh and calf, measured using MRI.

Research Summary

This multi-centre, assessor-blinded, randomised controlled trial will investigate the effectiveness of early exercise in preventing muscle atrophy and maintaining skeletal integrity after spinal cord injury. Fifty participants with acute SCI will be randomised to either a 12-week programme of FES-assisted cycling or passive cycling. The primary outcome is muscle cross-sectional area measured by MRI, with secondary outcomes including serum biomarkers, neurological function, and quality of life.

Practical Implications

Preventing Muscle Atrophy

Early FES-assisted cycling may prevent muscle atrophy and related complications like pressure ulcers.

Maintaining Skeletal Integrity

The intervention may help preserve skeletal structure by inhibiting sclerostin levels.

Improving Therapeutic Strategies

Understanding the mechanisms of active and passive exercise can lead to more effective treatments for SCI.

Study Limitations

1
Therapists and participants will not be blinded due to the nature of the intervention.
2
The trial is limited to participants with SCI above T12 and within 3 weeks of injury.
3
The study excludes participants with specific conditions like metabolic bone disease or contraindications to FES.

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