Study of Testosterone Replacement and Walking Training to Improve Bone and Muscle Health in Men with Spinal Cord Injury

What this Trial Is About

This research aims to evaluate a combined rehabilitation approach using testosterone replacement therapy TRT with locomotor training LT in men who have testosterone deficiency and walking difficulties after incomplete or complete spinal cord injury SCI. The study explores whether this combination can improve muscle size, bone mineral density, muscle function, and walking recovery in this group. It is a Phase 2 pilot study focused on men with low testosterone and ambulatory dysfunction following SCI. Participants will be divided into three groups one receiving weekly testosterone enanthate injections 100 mg, another receiving the same testosterone injections plus locomotor training involving treadmill and overground walking sessions four times per week for 2-3 months, and a non-treatment control group receiving no intervention. TRT will be administered for six months, with locomotor training occurring during the first 2-3 months alongside TRT in the combination group. During the study, participants will undergo assessments at baseline and at 1, 3, and 6 months, including MRI scans, DEXA scans to measure bone density, muscle performance tests, and walking ability evaluations such as the 6-minute walk test and 10-meter walk test. Safety evaluations will include physical exams, ECG, prostate exams, and blood tests monitoring hematocrit, liver enzymes, prostate-specific antigen, and other health markers. The study will compare outcomes among the three groups over six months to assess changes in muscle size, bone density, muscle strength, and walking function.

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury