NCT07588503 FES Cycling With BFR in the Spinal Cord Injury Population
| NCT ID | NCT07588503 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dr. B. Catharine. Craven |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2026-06-15 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * Adult (≥ 18 to ≤ 75yrs) * Male or female * Chronic Injury (\>1yr) * Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology. * ≥3 Cardiometabolic risk parameters Exclusion Criteria: * A prior or current history of venous thromboembolism * Pressure injury of the pelvis, mid to upper thigh region, or foot * Managing a lower limb fracture * Any history of embolic stroke * Myocardial infarction * Current untreated hypertension * Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and/or operate the device. * Current alcohol or street drug use disorder. * Current use of an anticoagulant medication. * Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week). * Unresolved deep vein thromboembolism (VTE) in the past six months. * Severe spasticity preventing the necessary range of motion for cycling. * Active implantable medical device (e.g., pacemaker, ITB pump). * Inability to provide informed consent. * Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores). * Unstable spine or unhealed limbs or pelvic fractures. * Active heterotopic ossification interfering with the lower extremity range of motion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07588503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07588503 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07588503 currently recruiting?
Yes, NCT07588503 is actively recruiting participants. Contact the research team at thomas.walden@uhn.ca for enrollment information.
Where is the NCT07588503 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT07588503 clinical trial?
NCT07588503 is sponsored by Dr. B. Catharine. Craven. The trial plans to enroll 6 participants.