NCT07588503RecruitingPhase 1
FES Cycling With BFR in the Spinal Cord Injury Population
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 15 Jun 2026
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Dr. B. Catharine. Craven
- Diseases
- Type 2 diabetes
- NCT number
- NCT07588503
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 6
- From 15 Jun 2026 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A prior or current history of venous thromboembolism
- Current use of an anticoagulant medication.
- Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).
- Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).
Other illness
- 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.
- Unresolved deep vein thromboembolism (VTE) in the past six months.
Other
- Pressure injury of the pelvis, mid to upper thigh region, or foot
- Managing a lower limb fracture
- Severe spasticity preventing the necessary range of motion for cycling.
- Active implantable medical device (e.g., pacemaker, ITB pump).
- Inability to provide informed consent.
- Unstable spine or unhealed limbs or pelvic fractures.
- Active heterotopic ossification interfering with the lower extremity range of motion.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lyndhurst Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.