Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Central Nervous System Diseases
- Androgen Deficiency
- Endocrine System Diseases
- Testosterone Deficiency
- Spinal Cord Diseases
- Gait Disorders, Neurologic
- Genital Diseases, Male
- Spinal Cord Injury
- Spinal Cord Trauma
- Gonadal Disorders
- Trauma Nervous System
- Hormone Deficiency
- Walking, Difficulty
- Hypogonadism
- Injuries, Spinal Cord
- Locomotion Disorder, Neurologic
- Nervous System Diseases
- Spinal Cord Injuries
- Wounds and Injuries
- Wounds and Injury
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Spinal cord injury (SCI) produces bone, muscle, and neural impairments that increase fracture risk and impede recovery of physical function. Locomotor training (LT) increases muscle size and promotes recovery of muscle function and walking in some persons with incomplete SCI. It is unknown if testos...
Spinal cord injury (SCI) produces bone, muscle, and neural impairments that increase fracture risk and impede recovery of physical function. Locomotor training (LT) increases muscle size and promotes recovery of muscle function and walking in some persons with incomplete SCI. It is unknown if testosterone replacement therapy (TRT) improves these factors in men who have walking dysfunction and low testosterone after incomplete SCI. In addition, the combined effects of LT plus TRT remain unknown in men with incomplete SCI. For this pilot study, men with incomplete SCI who have low testosterone and walking dysfunction will receive 6-months of TRT alone or TRT with LT. TRT injections will be given weekly. LT will involve 35 sessions of treadmill walking with assistance and overground walking (4 sessions per week) during the initial 2-3 months of TRT. Participants will be assessed at study entry and at 1-6 month intervals thereafter. Testing will include measurements such as a magnetic resonance imaging (MRI) scans, dual energy x-ray absorptiometry (DEXA) scan, and muscle performance and walking tests. Participants will also undergo safety tests, including physical exams, electrocardiogram (ECG), prostate digital rectal exam, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate specific antigen (PSA), and other health markers. The treatment groups will be compared with a non-treatment control group comprised of men with incomplete SCI who receive no treatment. Participants enrolled in the non-treatment control group will undergo the same tests described above.
Tracking Information
- NCT #
- NCT04460872
- Collaborators
- North Florida/South Georgia Veterans Health System
- Brooks Rehabilitation
- University of Florida
- Investigators
- Principal Investigator: Joshua F Yarrow, PhD North Florida/South Georgia Veterans Health System
Get Well Soon