RecruitingPhase 2NCT04460872

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

Locomotor Training With Testosterone to Promote Bone and Muscle Health


Sponsor

North Florida Foundation for Research and Education

Enrollment

21 participants

Start Date

Jan 31, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining testosterone therapy with locomotor (walking) training can improve bone density and muscle mass in men with spinal cord injury who also have low testosterone levels. Both low testosterone and reduced activity after spinal cord injury contribute to muscle loss and bone thinning. **You may be eligible if:** - You are a man over 18 with a spinal cord injury that occurred at least 60 days ago - Your injury involves upper motor neuron signs (spasticity or high muscle tone) - Your testosterone levels are below normal - You have at least one symptom of low testosterone (fatigue, low libido, muscle loss, bone loss, depression, etc.) - You have difficulty walking or walk slowly and rely on assistive devices **You may NOT be eligible if:** - You have prostate or breast cancer - You have very low red blood cell counts (severe anemia) or blood clotting problems - You have uncontrolled heart disease or severe liver disease - Your injury level or severity makes you ineligible based on specific clinical criteria - You are already on testosterone therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 System

Gainesville, Florida, United States

Brooks Rehabilitation

Jacksonville, Florida, United States

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NCT04460872


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