Actively Recruiting
FES Cycling With BFR in the Spinal Cord Injury Population
Led by Dr. B. Catharine. Craven · Updated on 2026-05-14
6
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
D
Dr. B. Catharine. Craven
Lead Sponsor
C
CAN-TAP-TALENT (CIHR Stream)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury/disease (SCI/D) population. Many SCI/D patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI/D population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI/D population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI/D population is a compelling and urgent health priority. Blood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the limb, shifting the way the muscles can produce the energy required to function, increasing the benefits of low- and moderate-intensity exercise. Coupling BFR with Functional electrical stimulation cycling (FES-cycling), a commonly used rehabilitation tool within the SCI population, could improve FES-cycling's short- and long-term benefits without reducing the accessibility and inclusiveness of long-term exercise prescription. Although preliminary BFR research in the SCI/D has identified positive muscular improvements, whether FES-cycling coupled with BFR can be safely prescribed or feasibly implemented long-term within the SCI/D population is unknown. The proposed project aims to determine the safety and feasibility of FES-cycling coupled with BFR for 20 minutes of moderate-intensity exercise among adults with chronic spinal cord injury/disease (SCI/D). The research team aims to implement pre-test, eight exercise sessions, and post-test across 6-weeks. Criteria for success include no adverse or severe adverse events not alleviated by ceasing exercise (safety), a 1 to 8 ratio of participants screened to participants eligible (recruitment success), and participants successfully completing all exercise sessions (participant retention).
CONDITIONS
Official Title
FES Cycling With BFR in the Spinal Cord Injury Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult aged 18 to 75 years
- Male or female
- Chronic spinal cord injury or disease for more than 1 year
- Diagnosis of spinal cord injury between levels C5 to T10 (AIS A-D), traumatic or non-traumatic
- At least 3 cardiometabolic risk parameters
You will not qualify if you...
- History of venous thromboembolism
- Pressure injury on pelvis, thigh, or foot
- Managing a lower limb fracture
- History of embolic stroke
- History of myocardial infarction
- Current untreated hypertension
- Language, psychiatric, cognitive, or communication disability affecting consent or participation
- Current alcohol or street drug use disorder
- Current use of anticoagulant medication
- Frequent episodes of autonomic dysreflexia unresponsive to therapy
- Unresolved deep vein thromboembolism in past 6 months
- Severe spasticity preventing cycling range of motion
- Active implantable medical device (e.g., pacemaker, ITB pump)
- Inability to provide informed consent
- Severe active medical conditions (e.g., skin or respiratory infections, lung conditions, pressure sores)
- Unstable spine or unhealed limb or pelvic fractures
- Active heterotopic ossification interfering with lower limb movement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lyndhurst Centre
Toronto, Ontario, Canada, M4G 3V9
Actively Recruiting
Research Team
T
Thomas P Walden, Ph.D
CONTACT
K
Katherine Chan, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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