Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
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
Traumatic
What’s involved
Type
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
About this trial
Included participants
What’s involved
Potential benefits
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