Multimodality Intervention for Function and Metabolism in SCI

Summary

The proposed phase 2 trial a randomized, placebo-controlled, parallel group trial in persons with cervical or thoracic SCI, AIS grade A, B, C, or D, 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 functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry and an androgen will be more efficacious than functional electrical stimulation during leg cycling (FES-LC) plus arm ergometry plus placebo in improving aerobic capacity, function, metabolism, bone health, and wellbeing.

Timeline

Start

2019-08-23

Primary completion

2025-01-15

Completion

2025-03-30

Publications

• Valderrabano RJ, Pencina K, Shang YV, Echevarria E, Dixon R, Ghattas C, Wilson L, Reid KF, Storer T, Garrahan M, Tedtsen T, Zafonte R, Bouxsein M, Bhasin S. Bone microarchitectural alterations associated with spinal cord injury: Relation to sex hormones, metabolic factors, and loading. Bone. 2024 Apr;181:117039. doi: 10.1016/j.bone.2024.117039. Epub 2024 Feb 5.
• Reid KF, Storer TW, Pencina KM, Valderrabano R, Latham NK, Wilson L, Ghattas C, Dixon R, Nunes A, Bajdek N, Huang G, Skeels SE, Lin AP, Merugumala SM, Liao HJ, Bouxsein ML, Zafonte RD, Bhasin S. 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. BMC Musculoskelet Disord. 2022 May 25;23(1):493. doi: 10.1186/s12891-022-05441-3.

Drugs

Indications