Home-Based Multimodality Intervention for Functional and Metabolic Improvement in Spinal Cord Injury Patients

This Phase 2 clinical trial investigates a home-based multimodality intervention designed to improve function and metabolism in individuals with spinal cord injuries (SCI). The study focuses on patients aged 19-70 years with cervical or thoracic SCI (AIS grade A-D) who are at least 6 months post-injury.

The primary objective is to evaluate whether a combination of functional electrical stimulation during leg cycling (FES-LC), arm ergometry, and testosterone therapy is more effective than exercise plus placebo in improving:

• Peak aerobic capacity
• Muscle mass and strength

Secondary objectives include assessing improvements in:

1. Metabolic health (glucose control, insulin sensitivity, body composition)
2. Bone density and strength
3. Physical function and overall wellbeing

The study design involves:

• 84 participants randomized into two groups
• 16-week intervention period
• Primary outcome measured by changes in aerobic capacity
• Multiple secondary outcomes including body composition, strength, and quality of life measures

Participants will undergo comprehensive assessments including:

• Cardiopulmonary testing
• MRI and DEXA scans
• Strength and endurance measurements
• Psychological and quality of life questionnaires

The study is conducted at Brigham and Women's Hospital in Boston, MA, with collaboration from Spaulding Rehabilitation Hospital and support from NICHD.