Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury

Drug
General health
Online since 5 November 2021, updated 886 days ago

About this trial

This trial is recruiting individuals with spinal cord injuries to assess modifications to a fitness program called Functional Electrical Stimulation Row Training (FESRT). The program involves using a rowing machine with volitional arm movements and skin-surface electrical stimulation of the weakened or paralyzed leg muscles. The modifications include an external breathing device (non-invasive ventilation; NIV) used during exercise and a drug called Buspar, taken orally twice daily for six months. Participants will complete 6 months of FESRT and will be randomly assigned to one of 4 study groups: 1) NIV + Buspar; 2) NIV + placebo; 3) sham NIV + Buspar; or 4) sham NIV + placebo drug. Training sessions will be conducted 2-3 times per week for 6 months. Final outcome assessments, including aerobic exercise capacity and ventilation during exercise, will be performed after 6 months.

Included participants

Gender
All
Age
18 - 50 years
Injury level
C1 - T3
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    Time since injury
    3 months - 36 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T3
    Additionally, participants must
    be a wheelchair user.
    NOT have epilepsy, heart disease, diabetes, or cancer

    What’s involved

    Type

    Drug

    Details

    The participant will train with a rowing machine using FESRT 2-3times/week for 6 months while receiving 1) NIV + Buspar, or 2) NIV + placebo, or 3) sham NIV + Buspar, or 4) sham NIV + placebo drug. Final outcome testing will be performed after 6 months.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    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
    • 22 Dec 2020
    • Organisation
    • Spaulding Rehabilitation Hospital
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Dec 2020
    • Organisation
    • Spaulding Rehabilitation Hospital

    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