RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-22
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04458324

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * SCI outpatients aged 18-45 years
  2. * medically stable
  3. * body mass index 18.5-30 kg/m2 to include normal to overweight but not obese individuals
  4. * 3-months to 6-years post-injury
  5. * ASIA Scale A, B, or C injury at or above neurological level T4
  6. * able to follow directions
  7. * wheelchair users
  8. * leg muscles responsive to stimulation
  1. * BP \>140/90 mmHg to exclude for hypertension (though rare in those with high level SCI)
  2. * current tobacco users
  3. * significant arrhythmias
  4. * coronary disease
  5. * diabetes
  6. * renal disease
  7. * cancer
  8. * epilepsy
  9. * current use of cardioactive medications (except medication to support blood pressure)
  10. * current grade 2 or greater pressure ulcers at relevant contact sites
  11. * other neurological disease
  12. * peripheral nerve compressions or rotator cuff tears that limit the ability to row
  13. * history of bleeding disorders
  14. * current use of buspirone
  15. * pregnancy
  16. * contraindications to Buspirone (taking MAO inhibitors, known hypersensitivity to buspirone, benzodiazepine dependence, akathisia, renal impairment, hepatic disease)

Contacts and Locations

Study Contact

Glen Picard, MA
CONTACT
617-758-5511
gpicard@partners.org

Study Locations (Sites)

Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-22
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2020-12-22
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Function Electrical Stimulation (FES)-Rowing

Additional Relevant MeSH Terms

  • Spinal Cord Injuries