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).
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.
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
Crossover
Blood Flow Restriction
DeviceBlood 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 interventionElectrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
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.
Safety - Skin Checks
Pre/post-session skin checks will be performed and findings recorded as a metric of safety.
Safety - Adverse Event Report
Any adverse or serious adverse events will be reported as per the hospital policy.
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.
Click on the lead sponsor to view all of their trials.
Dr. B. Catharine. Craven
Lead sponsor
Toronto Rehabilitation Institute
Sponsor institution
CAN-TAP-TALENT (CIHR Stream)
Collaborator
