Status:
COMPLETED
Blood Flow Restriction Exercise for Those With SCI
Lead Sponsor:
VA Office of Research and Development
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Spinal cord injuries (SCI) are among the most debilitating conditions an individual can sustain with the estimates of SCI incidence in the United States at 12,000 new cases per year. The loss of inner...
Detailed Description
This investigation is based on a within subject design. The investigators aim to recruit 16 individuals with diagnosed incomplete spinal cord injuries (level C3-L1, AISA C and D) to partake in two 8-w...
Eligibility Criteria
Inclusion
- All participants must be between the ages of 18 and 75 years and have a medically stable incomplete spinal cord injury (AIS C or D) at least 1-year post injury
- As the aim of this investigation is to focus on muscular and vascular adaptations to BFR exercise in the lower limbs, the level of injury must be between C3-L1
Exclusion
- The following are the exclusion criteria:
- Females that are pregnant
- Individuals required to have ventilator assist devices
- Individuals with significant active systemic disease, e.g. heart disease, renal failure/insufficiency and uncontrolled diabetes, uncontrolled hypertension and blood disorders that increase the risk for clot formation.
- Individuals with chronic inflammatory disease states (i.e. multiple sclerosis or rheumatoid arthritis, Guillen-Barre syndrome, chronic inflammatory demyelinating disorder and acute amyotrophic lateral sclerosis)
- Obese patients (\>30% body fat based on skinfold measurements)
- History of repeated DVTs or a DVT within the last year.
- Individuals currently taking vasodilators
- Individuals with orthopaedic limitations that would prevent them from performing knee extension/flexion exercise (with the exception of decreased strength due to the SCI)
- Individuals with uncontrolled spasticity or a history of frequent autonomic dysreflexia
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04889092
Start Date
July 1 2021
End Date
August 31 2024
Last Update
September 27 2024
Active Locations (1)
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1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702