FES Cycling + BFR for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to help individuals with long-term spinal cord injuries reduce their risk of heart disease and related conditions. The study tests a combination of two treatments: cycling with electrical stimulation (FES Cycling) and a specialized exercise using tight cuffs on the limbs to restrict blood flow (BFR, or blood flow restriction), which enhances the benefits of moderate exercise. The researchers aim to determine if these treatments are safe and feasible for long-term use. Individuals with spinal cord injuries from at least a year ago and specific health risks related to heart disease may be suitable candidates for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anticoagulant medications.
What prior data suggests that FES Cycling with BFR is safe for individuals with spinal cord injury/disease?
Research has shown that Functional Electrical Stimulation (FES) cycling, particularly when combined with Blood Flow Restriction (BFR), is generally safe for individuals with spinal cord injuries. Studies have found that this combination can enhance muscle health without adding strain to the heart or increasing pain. One study found that BFR exercise does not cause dangerous changes in blood pressure or raise the risk of blood clots. These findings suggest that both FES cycling and BFR are well-tolerated, making them promising options for those considering participation in this type of trial.12345
Why are researchers excited about this trial?
Researchers are excited about the FES Cycling with Blood Flow Restriction (BFR) treatment for spinal cord injury because it brings a fresh approach to rehabilitation. Unlike traditional therapies that often rely on passive physical therapy and medications, this method actively engages the muscles using electrical stimulation combined with BFR, which is thought to enhance muscle strength and endurance more effectively. The combination of FES and BFR is believed to improve blood flow and muscle activation, potentially leading to better functional outcomes in a shorter time frame compared to standard rehabilitation exercises. This dual approach could offer a significant advancement in helping individuals with spinal cord injuries regain mobility and independence.
What evidence suggests that FES Cycling with BFR could be effective for reducing CMD risk in the SCI/D population?
Research has shown that Functional Electrical Stimulation (FES) cycling can improve muscle health, strength, and fitness in people with spinal cord injuries (SCI). In this trial, participants will join one of two groups: one group will engage in FES cycling alone, while the other will add Blood Flow Restriction (BFR) to their FES cycling sessions. Studies suggest that adding BFR, which involves using cuffs to gently squeeze the muscles and reduce blood flow, can enhance exercise benefits. Evidence indicates that BFR is safe and beneficial for many, including those with SCI, without putting extra strain on the heart. Overall, this combination might help lower the risk of heart and metabolic diseases in people with SCI.12356
Are You a Good Fit for This Trial?
This trial is for adults with chronic spinal cord injury or disease. Participants should be able to safely use functional electrical stimulation cycling and not have any conditions that would make exercise unsafe, as determined by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-test
Participants undergo initial testing to establish baseline measurements
Treatment
Participants engage in FES-Cycling and FES-Cycling with BFR sessions
Post-test
Participants undergo final testing to assess changes post-intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FES Cycling With BFR
Trial Overview
The study tests if combining blood flow restriction (using inflatable cuffs) with functional electrical stimulation cycling is safe and practical for people with spinal cord injuries. Participants do moderate-intensity sessions over six weeks.
How Is the Trial Designed?
2
Treatment groups
Active Control
Four FES-Cycling exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.
Four FES-Cycling with BFR exercise sessions. Participants will complete 20 minutes of exercise two times a week for 2 weeks.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dr. B. Catharine. Craven
Lead Sponsor
CAN-TAP-TALENT (CIHR Stream)
Collaborator
Citations
FES Cycling With BFR in the Spinal Cord Injury Population
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury ...
Functional electrical stimulation cycling exercise after spinal ...
Current evidence indicates that FES cycling exercise improves lower-body muscle health of adults with SCI, and may increase power output and aerobic fitness.
FES Cycling With BFR in the Spinal Cord Injury Population
Participants will complete 20 minutes of exercise two times a week for 2 weeks. Treatment: Other: Functional Electrical Stimulated Cycling.
Effectiveness of Blood Flow Restriction in Neurological ...
There is scientific evidence that Blood Flow Restriction (BFR) is beneficial in healthy people, the elderly and patients with musculoskeletal disorders.
Effects of a Functional Electrical Stimulation–Assisted Cycling ...
The purpose of this study was to examine the effects of 12 weeks of FES training performed 3 times per week on physiological indices of cardiovascular function.
The Feasibility of Blood Flow Restriction Exercise in ...
Results suggest that controlled BFR exercise can be safely performed by individuals with iSCI without added cardiovascular strain or heightened pain.
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