A multimodality intervention to improve musculoskeletal health, function, metabolism, and well‑being in spinal cord injury: study protocol for the FIT‑SCI randomized controlled trial

This study aims to see if a combination of exercise (functional electrical stimulation leg cycling and arm ergometry) and testosterone treatment can improve health outcomes for people with spinal cord injuries. The study will involve 88 participants who will be randomly assigned to either receive the combined treatment or exercise with a placebo. Researchers will monitor aerobic capacity, muscle health, metabolic function, and overall well-being to determine the effectiveness of the intervention.

• 1
  The study hypothesizes that combining FES-LC plus AE with testosterone treatment will be more effective than FES-LC, AE, and a placebo in improving various health parameters.
• 2
  The primary outcome is the change in peak aerobic capacity, with secondary outcomes including body composition, muscle strength, metabolic profiles, and patient-reported well-being.
• 3
  The researchers anticipate that the multimodality intervention will result in increased aerobic capacity and greater improvements in musculoskeletal, metabolic, functional, and patient-reported outcomes.