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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorNorth Florida Foundation for Research and Education

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Testosterone Enanthate

    Drug

    Subjects receive testosterone (100 mg/week) by intramuscular injection

  • Locomotor Training

    Behavioral

    Subjects receive locomotor training (4 sessions/week for 2-3 months)

Treatment groups

21 Participants
are divided into 3 treatment groups
Group A: testosterone enanthateExperimental treatment 1 intervention
Group B: locomotor training, testosterone enanthateExperimental treatment 2 interventions
Group C: non-interventional controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

change in thigh muscle cross-sectional area

change in thigh muscle cross-sectional area assessed via MRI

Time frame
baseline, 3 months, 6 months
2

change in 6 min walk test (6MWT)

change in distance covered on 6MWT

Time frame
baseline, 1 month, 3 months, 6 months
3

change in distal femur bone mineral density

change in distal femur bone mineral density (BMD) assessed via DEXA

Time frame
baseline, 3 months, 6 months

Secondary outcomes

1

change in knee extensor peak torque

change in knee extensor peak torque assessed via dynamometry

Time frame
baseline, 3 months, 6 months
2

change in 10m walk test (10mWT)

change in time to complete 10mWT

Time frame
baseline, 1 month, 3 months, 6 months
3

change in bone resorption marker

change in circulating bone resorption marker

Time frame
baseline, 3 months, 6 months
4

change in bone formation marker

change in circulating bone formation marker

Time frame
baseline, 3 months, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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