NCT Number: NCT07588503
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).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 1
Toronto, Ontario, M4G 3V9, Canada
Location status: Recruiting
B.Catharine Craven, MD
PRINCIPAL_INVESTIGATOR
Katherine Chan, MSc
CONTACT
4165973422 ext. 6199
Kristin Musselman, Ph.D
SUB_INVESTIGATOR
Thomas P Walden, Ph.D
CONTACT
4165973422 ext. 6287
Background Spinal cord injury/disease (SCI/D) is a highly debilitating condition that results in motor, sensory, autonomic, and autoimmune impairments, which dramatically alters the individual's mobility, life, and health. Following injury, the individual's health is compromised by their primary impairment and secondary health conditions. Cardiometabolic Disease (CMD) refers to a collection of interrelated conditions (e.g., insulin resistance, chronic inflammation, and obesity) that increase the risk of cardiovascular and metabolic disease. CMD disease contributes to 46% of deaths within the SCI/D population. Currently, limited rehabilitation strategies exist that can effectively combat CMD risk factors among individuals living with an SCI/D. Therefore, identifying accessible, inclusive, and safe rehabilitation strategies to combat CMD risk among individuals living with an SCI/D is a compelling and urgent health priority.
Study Aim and Rationale The proposed project aims to investigate the safety and feasibility of functional electrical stimulation cycling (FES-Cycling) coupled with blood flow restriction (BFR). Preliminary studies examining BFR exercise within SCI/D individuals have reported positive findings. However, the pioneering BFR exercise research has not prescribed moderate-intensity aerobic exercise that mirrors the SCI/D weekly exercise guidelines. Therefore, whether BFR can be tolerated safely and practically in the SCI/D population is unknown.
Methods The proposed pilot study will utilize a convergent mixed methods approach and implement a pretest-post test quasi-experimental design. Six adults (18-75yrs) with chronic (>1yr) SCI/D will be recruited to participate in two testing sessions (pre/post), four FES-Cycling exercise sessions, and four FES-cycling coupled with BFR sessions across six weeks. Measures of safety, participant recruitment, and retention will be collected. A criterion of success will be developed for each measure. Descriptive statistics will be calculated and compared to the prior-defined success criterion. Deductive and inductive content analysis will assess participant feedback regarding exercise modality and protocol implementation.
Anticipated Results The research team expects to accomplish the success criteria for all measurement categories based on the existing evidence across the domains of FES-cycling and BFR exercise within SCI/D. Analysis of participant feedback will direct future protocol development and BFR prescription parameters.
Conclusions The proposed project is the first step towards developing a low-cost, highly accessible exercise accessory that could potentially maximize the physiological yield of aerobic and resistance exercise, increasing the potential protective abilities of exercise against CMD risk.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: KAATSU
Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
Time frame: 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.
Time frame: 6 weeks
Pre/post-session skin checks will be performed and findings recorded as a metric of safety.
Time frame: 6 weeks
Any adverse or serious adverse events will be reported as per the hospital policy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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 (%).
Time frame: 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).
Time frame: Six weeks - From enrollment to the end of the exercise protocol.
Pre- and Post-intervention participants' waist circumference will be measured and reported (cm)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Dr. B. Catharine. Craven
Other
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population
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