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

Drug

Standing/walking/mobility

Online since 5 November 2021, updated 894 days ago

About this trial

This trial is recruiting men with chronic incomplete spinal cord injuries to test the effect of combining testosterone replacement therapy (TRT) with treadmill and overground walking training. Participants will receive 6 months of either weekly TRT injections only; weekly TRT injections with walking training; or no treatment. The walking training group will receive 35 sessions of treadmill and overground walking with assistance during the initial 2-3 months. Assessments will include changes in the thigh muscle cross-sectional area, walking speed and bone density.

Included participants

Gender

Male

Age

≥ 18 years

Injury level

C1 - T12

Severity (AIS)?

AIS-A

AIS-B

AIS-C

AIS-D

Time since injury

≥ 12 months

Injury type

Traumatic

Non-traumatic

Healthy volunteers

C1-T12

Additionally, participants must

have low testosterone levels

have one or more symptom that may be related to low testosterone, e.g., loss of body hair, reduced sexual desire (libido), etc.

have difficulty or be unable to walk without assistance

What’s involved

Type

Drug

Details

The participant will receive 6 months of either: weekly TRT injections with walking training; weekly TRT injections without walking training; or no intervention. For those receiving walking training sessions, there will be a total of 35 sessions (occurring 4 times/week) during the first 2-3 months.

Potential benefits

Main benefits

Standing/walking/mobility

Additional benefits

Bone health

General health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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