Recruiting
Phase 1

FES-Cycling & BFR

Sponsor:

Dr. B. Catharine. Craven

Code:

NCT07588503

Conditions

Spinal Cord Injury

Cardio Vascular Disease

Metabolic Diseases, Type 2 Diabetes, Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Blood Flow Restriction

Functional Electrical Stimulated Cycling

Study Details

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

Study ID

NCT07588503

Start date

Jun 15, 2026

Status verified date

May, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Functional Electrical Stimulated Cycling

Four FES-Cycling exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.

active comparator: Functional Electrical Stimulated Cycling with Blood Flow Restriction

Four FES-Cycling with BFR exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.

Interventions

Blood Flow Restriction

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 Cycling

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

Primary outcome measure

  • Participant Retention [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Safety - Skin Checks [ Time Frame: 6 weeks ]
  • Safety - Adverse Event Report [ Time Frame: 6 weeks ]
  • Recruitment Rate [ Time Frame: 2 to 3 months, depending on how successful the recruitment process is. ]
  • Change in CMD Risk Profile - Lipid Profile [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Participant Perspectives and Experience [ Time Frame: 6 weeks ]
  • Safety - Heart Rate [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Safety - Blood Pressure [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Safety - Oxygen Saturation [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Safety - Rating of Perceived Exertion and Discomfort. [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Change in CMD Risk Profile - C-Reactive Protein [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Change in CMD Risk Profile - Hemoglobin A1c [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Change in CMD Risk Profile - Fasted Plasma Glucose [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Change in CMD Risk Profile - Waist Circumference [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]
  • Change in CMD Risk Profile - Body Mass Index [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]

Central Contacts and Locations

Central contacts

Thomas P Walden, Ph.D

4165973422thomas.walden@uhn.ca

Katherine Chan, MSc

4165973422Katherine.chan@uhn.ca

Locations

Lyndhurst Centre

Recruiting

Toronto, Ontario, Canada, M4G 3V9

Contacts

Thomas P Walden, Ph.D

4165973422thomas.walden@uhn.ca

Katherine Chan, MSc

4165973422Katherine.chan@uhn.ca

Principal Investigator:

B.Catharine Craven, MD

More Information

Sponsor

Dr. B. Catharine. Craven

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. B. Catharine. Craven on 2026-05-14.