FES Cycling With BFR in the Spinal Cord Injury Population

Sponsor
Dr. B. Catharine. Craven
Study ID
NCT07588503
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • Functional Electrical Stimulated Cycling — OTHER
    Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.

Study Details

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).

Key Dates

First listed
May 14, 2026
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jan 1, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

Primary Outcome Measure

Participant Retention [ Time Frame: Six weeks - From enrollment to the end of the exercise protocol. ]

Central Contacts

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