Improving Function and Metabolism in Spinal Cord Injury
“Multimodality Intervention for Function and Metabolism in SCI”
This study is a phase 2, randomized, placebo-controlled, parallel group trial in persons with C7-T12 motor level SCI, AIS grade A, B or C, 6 months or later after injury. The trial will test the hypothesis that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement Program that addresses multiple pathophysiologic factors in SCI and includes hybrid exercise (Functional electrical stimulation - leg cycling, FES-LC plus arm ergometry), and an androgen will be more efficacious than hybrid exercise plus placebo in improving aerobic capacity, function, metabolism, and wellbeing.
Drug - Testosterone Undecanoate
administered through injections by study staff
Behavioral - hybrid exercise
hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
Effect of a Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury