RecruitingPHASE1INTERVENTIONAL

FES Cycling With BFR in the Spinal Cord Injury Population

This study explores a new exercise method for adults with spinal cord injury to help reduce their risk of heart disease and related health problems. These health issues, often called cardiometabolic disease, are a major concern for people with spinal cord injury and can be life-threatening. The research combines two techniques: Functional Electrical Stimulation (FES) cycling, which uses gentle electrical pulses to make muscles work, and Blood Flow Restriction (BFR), where special cuffs are used on the limbs to make exercise more effective. The study aims to find out if this combined approach is safe and practical for people with spinal cord injuries, and if it can improve their long-term health.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Dr. B. Catharine. Craven

Enrolment target

Start

15 Jun 2026

Estimated completion

30 Sep 2027

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

What is this study about?

For people living with a spinal cord injury, there's a higher risk of developing certain health problems over time, especially those affecting the heart and blood vessels. These conditions, which doctors call 'cardiometabolic diseases,' can be quite serious and often go unnoticed. They include things like higher blood sugar, weight gain, and inflammation, and can eventually lead to heart attacks or strokes. Finding good ways to help prevent or manage these risks is really important for people with spinal cord injuries.

This study is looking into a new way to exercise that might help. It brings together two techniques: Functional Electrical Stimulation (FES) cycling, where mild electrical pulses help your leg muscles move, and Blood Flow Restriction (BFR), where special inflatable cuffs on your arms or legs make your muscles work harder with less effort. Both of these treatments are already used in different ways, but combining them for people with spinal cord injuries to tackle heart and blood vessel risks is a new idea.

The main goal of this particular study is to check if this combined FES cycling and BFR exercise is safe and practical for people with chronic spinal cord injuries. The research team wants to see if participants can easily do the exercises and if there are any unexpected problems. If it proves safe and possible to do, it could open the door for larger studies to confirm if this new exercise routine can really make a difference in reducing the risk of heart disease for people with spinal cord injuries.

Key takeaways

The study explores a new exercise for people with spinal cord injury.
It combines FES cycling with blood flow restriction.
The main goal is to check if this exercise is safe and practical.
It aims to reduce the risk of heart and blood vessel problems.
Participation involves 2 tests and 8 exercise sessions over 6 weeks.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have a spinal cord injury that happened at least a year ago. Your injury should be between the C5 and T10 levels (which is a way doctors describe the location of your injury) and you should have at least three risk factors for cardiometabolic disease, such as certain blood sugar levels or waist measurements.

There are also some reasons why you might not be able to join. For example, if you've recently had a blood clot or a stroke, or if you have certain active health problems like serious skin sores, unhealed broken bones, or particular heart conditions. You also can't participate if you have an active medical implant like a pacemaker, or if you're taking blood-thinning medication. The study can't include people with severe uncontrolled high blood pressure or frequently occurring severe muscle spasms that aren't managed by treatment.

If you have a condition that affects your memory, communication, or ability to understand clearly, or if you currently misuse alcohol or street drugs, you wouldn't be able to join. These rules are in place to make sure the study is safe for everyone involved and that results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Has it been more than one year since your spinal cord injury?
Do you have at least three risk factors for heart or blood sugar problems?
Do you NOT have a recent history of blood clots or stroke?
Do you NOT have serious unhealed skin sores or broken bones?
Are you NOT taking blood-thinning medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a 'pre-test' session to check some health details. After that, over six weeks, you'll attend eight exercise sessions. These sessions will involve FES cycling, sometimes with the added blood flow restriction technique. The exercise itself will be for about 20 minutes each time. At the end of the six weeks, you'll have a 'post-test' session to see if there have been any changes. The researchers will be checking things like safety, how many people participate, and how many complete all the sessions. In total, your participation would involve two testing sessions and eight exercise sessions over a six-week period.

Potential risks and benefits

This study is a first step to see if this combined exercise method is safe and practical. While we don't know the full benefits yet, potential upsides could include finding a new, effective way to exercise that helps reduce your risk of heart and blood vessel problems in the long run. As with any exercise or medical study, there are potential risks, such as discomfort during exercise or minor side effects while using the blood flow restriction cuffs. The study aims to identify and manage any such risks carefully. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Lyndhurst Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is FES cycling?

FES cycling uses gentle electrical pulses to stimulate your leg muscles, helping them contract and pedal a special bike, even if you can't move them on your own.

What is Blood Flow Restriction (BFR)?

BFR involves wearing inflatable cuffs on your arms or legs during exercise. These cuffs lightly restrict blood flow, making your muscles work harder with less effort than traditional exercise.

Why is this exercise important for spinal cord injury?

People with spinal cord injury are at higher risk of heart disease and related health issues. This exercise aims to find a safe and effective way to help reduce that risk.

How long does the study last?

If you take part, the study will involve two testing sessions and eight exercise sessions over a total period of six weeks.

Will I get paid to participate?

The study information provided does not say if participants will receive payment for taking part. You should ask the research team about this.

How to find out more

Thomas P Walden, Ph.D

thomas.walden@uhn.ca 4165973422 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.