Actively Recruiting
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
Led by North Florida Foundation for Research and Education · Updated on 2025-05-06
21
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
N
North Florida Foundation for Research and Education
Lead Sponsor
N
North Florida/South Georgia Veterans Health System
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men over 18 years of age
- Diagnosis of incomplete SCI involving spinal segments L1 or above, or clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs for more than 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 signs or symptoms related to low testosterone, such as reduced body hair, small testes, low libido, erectile dysfunction, breast discomfort, height loss, low-trauma fracture, low bone mineral density, hot flushes, mood changes, fatigue, poor concentration, sleep disturbances, mild anemia, reduced muscle bulk or strength, increased body fat, or other associated symptoms
- Locomotor dysfunction defined by self-selected walking speed ≤1.0 m/s on a 10-meter walk test, with or without gait devices or assistance
- First-time SCI diagnosis from trauma, vascular, or orthopedic causes
- Medically stable with no symptoms interfering with study participation
- Willingness to administer TRT as directed and follow study protocol
- Documented medical approval verifying participant's health status
You will not qualify if you...
- Participation in another research protocol that may influence outcomes
- Mental state preventing understanding of the study protocol
- Life expectancy less than 12 months
- History or current congenital SCI or degenerative spinal disorders complicating study procedures
- Multiple sclerosis, amyotrophic lateral sclerosis, or other neurological impairments
- Current or history of prostate, breast, or other organ cancers within past 24 months (except treated skin basal or squamous cell carcinoma)
- Serum PSA >3.0 ng/mL (with exceptions for men on certain medications)
- Prostate abnormalities detected on exam indicating cancer
- Seeking or expecting fertility during the study
- Gynecomastia
- Hematocrit >49%
- Major cardiovascular events in the past 12 months or certain uncontrolled heart conditions
- Poorly controlled hypertension or arrhythmias
- Severe valvular heart disease
- ECG abnormalities precluding ongoing evaluation
- History of unprovoked blood clots or known clotting disorders
- High LDL cholesterol with recent major cardiovascular events
- Recent major surgeries within 90 days or planned major surgeries
- Elevated liver enzymes beyond 1.5 times normal
- Severe kidney disease
- Untreated severe obstructive sleep apnea
- Recent lower extremity fractures or low bone density (for combination treatment group)
- Current anticoagulant use
- Recent use of testosterone or related hormonal treatments
- Recent use of bone therapy drugs
- Recent acute opioid or systemic steroid use unless chronic and expected to continue
- Allergy to TRT components
- Any other condition or treatment posing risk, interfering with participation, or confounding results
Research Team
J
Joshua F Yarrow, PhD
D
Dana M Otzel, PhD
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