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

Drug
Standing/walking/mobility
Online since 5 November 2021, updated 925 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
    No
    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.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 31 Jan 2021
    • Organisation
    • North Florida Foundation for Research and Education
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 31 Jan 2021
    • Organisation
    • North Florida Foundation for Research and Education

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more