Locomotor Training With Testosterone to Promote Bone and Muscle Health
North Florida Foundation for Research and Education
Summary
This pilot study will determine the feasibility of implementing a combinatory rehabilitation strategy involving testosterone replacement therapy (TRT) with locomotor training (LT; walking on a treadmill with assistance and overground walking) in men with testosterone deficiency and walking dysfunction after incomplete or complete spinal cord injury. The investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater incomplete SCI.
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 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 involving spinal level L1…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Men \>18 years of age * Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for \>60-days * Low serum total testosterone (\<300 ng/dL), bioavailable testosterone (\<110 ng/dL), or free testosterone (\<46 pg/mL or \<4.6 ng/dL) * Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (\<6 mL), reduced sexual desire (libido) and activi…
Interventions
- DrugTestosterone Enanthate
Subjects receive testosterone (100 mg/week) by intramuscular injection
- BehavioralLocomotor Training
Subjects receive locomotor training (4 sessions/week for 2-3 months)
Locations (2)
- North Florida/South Georgia Veterans Health SystemGainesville, Florida
- Brooks RehabilitationJacksonville, Florida