FES Cycling With BFR in the Spinal Cord Injury Population

NCT07588503 | Recruiting Phase 1 DMC

• 1 other identifier: 25-5288
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury; Cardio Vascular Disease; Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Keywords

Safety; Feasability; Spinal Cord Injury; Blood Flow Restricted Aerobic Exercise; Functional Electrical Stimulation; Cycling

Outcome Measures

Primary Outcomes (15)

• 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.

  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.

  6 weeks

• Safety - Adverse Event Report

  Any adverse or serious adverse events will be reported as per the hospital policy.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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 (%).

  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).

  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)

  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)

  Six weeks - From enrollment to the end of the exercise protocol.

Study Arms (2)

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.

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.

Device: Blood Flow Restriction; Other: Functional Electrical Stimulated Cycling

Interventions

Blood Flow Restriction DEVICE

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.

Also known as: KAATSU

Functional Electrical Stimulated Cycling with Blood Flow Restriction

Functional Electrical Stimulated Cycling OTHER

Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.

Functional Electrical Stimulated Cycling; Functional Electrical Stimulated Cycling with Blood Flow Restriction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. B. Catharine. Craven: lead
• CAN-TAP-TALENT (CIHR Stream): collaborator

Study Sites (1)

Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Metabolic Diseases; Diabetes Mellitus, Type 2; Cardiovascular Diseases

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Thomas P Walden, Ph.D

CONTACT

4165973422; thomas.walden@uhn.ca

Katherine Chan, MSc

CONTACT

4165973422; Katherine.chan@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientist - Principal Investigator

Model Details: The proposed pilot study will utilize a convergent mixed methods approach and implement a pretest-post test quasi-experimental design.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)