Exercise program using electrical stimulation to improve breathing in spinal cord injury patients
Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
PHASE2 · Spaulding Rehabilitation Hospital · NCT04458324
This study is testing if a special exercise program using electrical stimulation can help young adults with high-level spinal cord injuries breathe better and improve their fitness.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital (other) |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT04458324 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a unique exercise program called Functional Electrical Stimulation Row Training (FESRT) combined with two methods of improving ventilation in patients with high-level spinal cord injuries. Participants will be randomly assigned to receive either non-invasive ventilation (NIV) or a placebo while engaging in FESRT, which involves both arm and leg exercises. The study aims to determine if these interventions can enhance aerobic capacity by overcoming ventilatory limitations associated with high-level spinal cord injuries. The trial will include outpatients aged 18-45 who are medically stable and have specific spinal cord injury classifications.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18-45 with high-level spinal cord injuries (T4 and above) who are medically stable and can follow directions.
Not a fit: Patients with significant comorbidities such as coronary disease, diabetes, or those currently using buspirone may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve aerobic capacity and overall health for individuals with high-level spinal cord injuries.
How similar studies have performed: Previous studies have shown that non-invasive ventilation can improve exercise capacity in patients with restrictive breathing, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * SCI outpatients aged 18-45 years * medically stable * body mass index 18.5-30 kg/m2 to include normal to overweight but not obese individuals * 3-months to 6-years post-injury * ASIA Scale A, B, or C injury at or above neurological level T4 * able to follow directions * wheelchair users * leg muscles responsive to stimulation Exclusion Criteria: * BP \>140/90 mmHg to exclude for hypertension (though rare in those with high level SCI) * current tobacco users * significant arrhythmias * coronary disease * diabetes * renal disease * cancer * epilepsy * current use of cardioactive medications (except medication to support blood pressure) * current grade 2 or greater pressure ulcers at relevant contact sites * other neurological disease * peripheral nerve compressions or rotator cuff tears that limit the ability to row * history of bleeding disorders * current use of buspirone * pregnancy * contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)
Where this trial is running
Cambridge, Massachusetts
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Glen Picard, MA
- Email: gpicard@partners.org
- Phone: 617-758-5511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, Function Electrical Stimulation-Rowing