Spinal Cord InjuryPhase 1NCT07588503
FES Cycling With BFR in the Spinal Cord Injury Population
A Phase 1 study testing Blood Flow Restriction and Functional Electrical Stimulated Cycling in people with Spinal Cord Injury and Cardio Vascular Disease, run by Dr. B. Catharine. Craven at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Cardio Vascular Disease, Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
- What is being tested?
- Blood Flow Restriction and Functional Electrical Stimulated Cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2026to 30 Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Lyndhurst Centre
Toronto, Ontario, M4G 3V9
Thomas P Walden, Ph.D, 4165973422 ext. 6287, thomas.walden@uhn.ca
Katherine Chan, MSc, 4165973422 ext. 6199, Katherine.chan@uhn.ca
About this study
Official title: Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population
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).
Read the detailed description
Background Spinal cord injury/disease (SCI/D) is a highly debilitating condition that results in motor, sensory, autonomic, and autoimmune impairments, which dramatically alters the individual's mobility, life, and health. Following injury, the individual's health is compromised by their primary impairment and secondary health conditions. Cardiometabolic Disease (CMD) refers to a collection of interrelated conditions (e.g., insulin resistance, chronic inflammation, and obesity) that increase the risk of cardiovascular and metabolic disease. CMD disease contributes to 46% of deaths within the SCI/D population. Currently, limited rehabilitation strategies exist that can effectively combat CMD risk factors among individuals living with an SCI/D. Therefore, identifying accessible, inclusive, and safe rehabilitation strategies to combat CMD risk among individuals living with an SCI/D is a compelling and urgent health priority.
Study Aim and Rationale The proposed project aims to investigate the safety and feasibility of functional electrical stimulation cycling (FES-Cycling) coupled with blood flow restriction (BFR). Preliminary studies examining BFR exercise within SCI/D individuals have reported positive findings. However, the pioneering BFR exercise research has not prescribed moderate-intensity aerobic exercise that mirrors the SCI/D weekly exercise guidelines. Therefore, whether BFR can be tolerated safely and practically in the SCI/D population is unknown.
Methods The proposed pilot study will utilize a convergent mixed methods approach and implement a pretest-post test quasi-experimental design. Six adults (18-75yrs) with chronic (>1yr) SCI/D will be recruited to participate in two testing sessions (pre/post), four FES-Cycling exercise sessions, and four FES-cycling coupled with BFR sessions across six weeks. Measures of safety, participant recruitment, and retention will be collected. A criterion of success will be developed for each measure. Descriptive statistics will be calculated and compared to the prior-defined success criterion. Deductive and inductive content analysis will assess participant feedback regarding exercise modality and protocol implementation.
Anticipated Results The research team expects to accomplish the success criteria for all measurement categories based on the existing evidence across the domains of FES-cycling and BFR exercise within SCI/D. Analysis of participant feedback will direct future protocol development and BFR prescription parameters.
Conclusions The proposed project is the first step towards developing a low-cost, highly accessible exercise accessory that could potentially maximize the physiological yield of aerobic and resistance exercise, increasing the potential protective abilities of exercise against CMD risk.
- Conditions
- Spinal Cord Injury, Cardio Vascular Disease, Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease
- Being tested
- Blood Flow Restriction, Functional Electrical Stimulated Cycling
- Keywords
- Safety, Feasability, Spinal Cord Injury, Blood Flow Restricted Aerobic Exercise, Functional Electrical Stimulation, Cycling
- Medical subject headings
- Spinal Cord Injuries, Metabolic Diseases, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
Also called KAATSU
Blood Flow Restriction (BFR) exercise is a training method where a specialized cuff or band is applied to the top of a limb (arm or leg) to partially restrict blood flow during exercise.
Functional Electrical Stimulated CyclingOther
Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulated Cycling | Active comparator | Four FES-Cycling exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks. Receives: Other: Functional Electrical Stimulated Cycling |
| Functional Electrical Stimulated Cycling with Blood Flow Restriction | Active comparator | Four FES-Cycling with BFR exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks. Receives: Device: Blood Flow Restriction; Other: Functional Electrical Stimulated Cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Retention
For a long-term clinical trial spanning 3 to 6 months of data collection per participant, the research team would estimate an approximate retention rate of 80%. Therefore, our criteria for successful participant retention as a feasibility assessment is having a maximum of two recruited participants who do not complete the 4-week protocol.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Safety - Skin Checks
Pre/post-session skin checks will be performed and findings recorded as a metric of safety.
Measured: 6 weeks
Safety - Adverse Event Report
Any adverse or serious adverse events will be reported as per the hospital policy.
Measured: 6 weeks
Recruitment Rate
Our criteria for success in recruiting six participants is 2 to 3 months. The time taken to successfully recruit 6 participants will be reported.
Measured: 2 to 3 months, depending on how successful the recruitment process is.
Change in CMD Risk Profile - Lipid Profile
Participants will have a blood draw pre- and post-exercise intervention. Participants' fasting lipid profiles will be assessed. All aspects will be reported as millimoles per litre (mmol/L) and will involve: total cholesterol, low-density cholesterol, high-density cholesterol and triglycerides.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Participant Perspectives and Experience
Participant satisfaction is fundamental to implementing a successful long-term clinical trial. The interview guide will use a combination of structured and semi-structured interview techniques during the follow-up session to gain the participant's perspectives on the implemented protocol, elements they enjoy and elements they did not. After study completion, one-on-one semi-structured interviews (in-person or via MS Teams) lasting approximately 45-60 minutes will be conducted to explore participants' perceptions of recruitment approaches, elements they enjoy and elements they did not. Interviews will be voiced record and word for word transcribed for batch analysis at the completion of the entire study. This will allow us to look beyond the efficacy of the novel exercise technique and consider its level of practicality, acceptability and scalability within the SCI population. Participants that choose to withdraw will not be interviewed.
Measured: 6 weeks
Safety - Heart Rate
Heart rate will be measured at fixed time points pre- and post-session and continuously throughout the exercise period. Heart Rate will be recorded as beats per minute.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Safety - Blood Pressure
Blood pressure will be recorded at a fixed time point pre- and post-session, and at two-minute increments throughout the exercise period. Systolic and Diastolic blood pressure will be reported as millimetres of mercury.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Safety - Oxygen Saturation
Oxygen saturation will be collected at a fixed time point pre- and post-session, and at two-minute increments throughout the exercise period. Oxygen saturation will be measured as a percentage of available hemoglobin binding sites occupied by oxygen.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Safety - Rating of Perceived Exertion and Discomfort.
Ratings of perceived exertion and discomfort will be recorded at two-minute increments during the exercise period and at a fixed time point post-exercise. Both perceived exertion and discomfort will be rated on a scale from 0 to 10.
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Change in CMD Risk Profile - C-Reactive Protein
Participants will have a blood draw pre- and post-exercise intervention. Participants' C-Reactive Protein levels will be reported as milligrams per litre (mg/L).
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Change in CMD Risk Profile - Hemoglobin A1c
From the Pre-/post-intervention blood draws participant's Hemoglobin A1c will be reported as a percentage (%).
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Change in CMD Risk Profile - Fasted Plasma Glucose
From the pre-/post-intervention blood draws, participants' Fasted Plasma Glucose will be reported as millimoles per litre (mmol/L).
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Change in CMD Risk Profile - Waist Circumference
Pre- and Post-intervention participants' waist circumference will be measured and reported (cm)
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Change in CMD Risk Profile - Body Mass Index
Pre- and Post-intervention participants height (cm) and weight (kg) will be recorded and Body Mass index calculated and reported (kg/m²)
Measured: Six weeks - From enrollment to the end of the exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start15 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The proposed pilot study will utilize a convergent mixed methods approach and implement a pretest-post test quasi-experimental design.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. B. Catharine. Craven
- Sponsor type
- University, hospital or other
- Collaborators
- CAN-TAP-TALENT (CIHR Stream)
- Responsible party
- Sponsor-investigator, Dr. B. Catharine. Craven, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588503
- Sponsor's protocol ID
- 25-5288
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary data of the primary variables