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

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record status
This record was last updated March 5, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jul 31, 2025 to Jul 31, 2026v7 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jul 31, 2026 to Jul 31, 2027
    • Eligibility criteria revised
    • Site details revised
  2. Eligibility criteria expanded, about 4 wordsv6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary completion date: Dec 31, 2024 to Jul 31, 2025
    • Start date: Sep 30, 2020 to Dec 22, 2020
    • Study completion date: Jun 30, 2025 to Jul 31, 2026
    • Eligibility criteria revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 31, 2020 to Sep 30, 2020
    • Secondary endpoints: details revised at 1 of 11 entries
    • Site details revised
    v3
  6. Secondary endpoints: details revised at 1 of 11 entries
    • Study description expanded, about 2 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity. This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports. In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.
Trial Details
NCT Number NCT04458324
Lead Sponsor Spaulding Rehabilitation Hospital
Conditions
(from sponsor)		 Spinal Cord Injuries
Related terms Spinal Cord Injuries
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov