FES Cycling With BFR in the Spinal Cord Injury Population

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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).

Eligibility

Primary outcome measure(s)

• Participant Retention — Six weeks - From enrollment to the end of the exercise protocol.
  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 — 6 weeks
  Pre/post-session skin checks will be performed and findings recorded as a metric of safety.
• Safety - Adverse Event Report — 6 weeks
  Any adverse or serious adverse events will be reported as per the hospital policy.
• Recruitment Rate — 2 to 3 months, depending on how successful the recruitment process is.
  Our criteria for success in recruiting six participants is 2 to 3 months. The time taken to successfully recruit 6 participants will be reported.
• Change in CMD Risk Profile - Lipid Profile — Six weeks - From enrollment to the end of the exercise protocol.
  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.
• Participant Perspectives and Experience — 6 weeks
  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.
• Safety - Heart Rate — Six weeks - From enrollment to the end of the exercise protocol.
  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.
• Safety - Blood Pressure — Six weeks - From enrollment to the end of the exercise protocol.
  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.
• Safety - Oxygen Saturation — Six weeks - From enrollment to the end of the exercise protocol.
  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.
• Safety - Rating of Perceived Exertion and Discomfort. — Six weeks - From enrollment to the end of the exercise protocol.
  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.
• Change in CMD Risk Profile - C-Reactive Protein — Six weeks - From enrollment to the end of the exercise protocol.
  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).
• Change in CMD Risk Profile - Hemoglobin A1c — Six weeks - From enrollment to the end of the exercise protocol.
  From the Pre-/post-intervention blood draws participant's Hemoglobin A1c will be reported as a percentage (%).
• Change in CMD Risk Profile - Fasted Plasma Glucose — Six weeks - From enrollment to the end of the exercise protocol.
  From the pre-/post-intervention blood draws, participants' Fasted Plasma Glucose will be reported as millimoles per litre (mmol/L).
• Change in CMD Risk Profile - Waist Circumference — Six weeks - From enrollment to the end of the exercise protocol.
  Pre- and Post-intervention participants' waist circumference will be measured and reported (cm)
• Change in CMD Risk Profile - Body Mass Index — Six weeks - From enrollment to the end of the exercise protocol.
  Pre- and Post-intervention participants height (cm) and weight (kg) will be recorded and Body Mass index calculated and reported (kg/m²)

Trial sites (1)

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