About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone
Disqualifiers
Currently participating in another research protocol that may influence study outcomes.
Mental state that precludes understanding the study protocol.
Life expectancy <12-months.
History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures
Trial design
Parallel
Treatments tested in this trial
Testosterone Enanthate
DrugSubjects receive testosterone (100 mg/week) by intramuscular injection
Locomotor Training
BehavioralSubjects receive locomotor training (4 sessions/week for 2-3 months)
Treatment groups
Trial outcomes
Primary outcomes
change in thigh muscle cross-sectional area
change in thigh muscle cross-sectional area assessed via MRI
change in 6 min walk test (6MWT)
change in distance covered on 6MWT
change in distal femur bone mineral density
change in distal femur bone mineral density (BMD) assessed via DEXA
Secondary outcomes
change in knee extensor peak torque
change in knee extensor peak torque assessed via dynamometry
change in 10m walk test (10mWT)
change in time to complete 10mWT
change in bone resorption marker
change in circulating bone resorption marker
change in bone formation marker
change in circulating bone formation marker
Sponsors and contacts
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North Florida Foundation for Research and Education
Lead sponsor
North Florida/South Georgia Veterans Health System
Collaborator
Brooks Rehabilitation
Collaborator
University of Florida
Collaborator
VA Eastern Colorado Health Care System
Collaborator