Status:
RECRUITING
Hybrid Functional Electrical Stimulation Exercise to Prevent Cardiopulmonary Declines in High-level Spinal Cord Injury
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-40 years
Phase:
PHASE2
Brief Summary
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 Trai...
Detailed Description
Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. The investigators...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04458324
Start Date
December 22 2020
End Date
July 31 2026
Last Update
January 4 2023
Active Locations (1)
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1
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138