Trial Summary
What is the purpose of this trial?This trial tests whether using electrical impulses to stimulate muscles during cycling can help people with MS who have trouble moving. The goal is to see if this approach can improve muscle strength and mobility better than current treatments.
Is FES Cycling Exercise a promising treatment for people with Multiple Sclerosis?Yes, FES Cycling Exercise is a promising treatment for people with Multiple Sclerosis. It helps reduce fatigue, improve quality of life, and offers a safe exercise option for those with significant mobility challenges.13456
What safety data is available for FES cycling in MS patients?The safety of FES cycling for individuals with multiple sclerosis (MS) has been evaluated in several studies. These studies indicate that FES cycling is a safe exercise option for people with MS, including those who are nonambulatory. Research has focused on the safety, feasibility, and potential benefits of FES cycling, such as improvements in fatigue, pain, spasticity, and quality of life. Overall, FES cycling is considered a safe and beneficial exercise modality for individuals with moderate-to-severe MS.34567
What data supports the idea that FES Cycling for Multiple Sclerosis is an effective treatment?The available research shows that FES Cycling can be an effective treatment for people with Multiple Sclerosis (MS), especially those who cannot walk. Studies indicate that FES Cycling helps reduce fatigue and improve the quality of life for these individuals. It also has positive effects on cognition, pain, and overall health-related quality of life. Additionally, FES Cycling is considered safe and beneficial for people with significant weakness and mobility challenges due to MS. This suggests that FES Cycling can be a valuable exercise option for managing symptoms and enhancing well-being in people with MS.23567
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications, but you must not have used dalfampridine in the past month.
Eligibility Criteria
This trial is for people with Multiple Sclerosis who can visit the University of Ottawa for sessions, have an EDSS score between 5.0 and 7.0, haven't had a relapse in the last month, been on stable MS therapies for six months, are not pregnant or have conditions like epilepsy that make FES unsafe.Inclusion Criteria
I don't have symptoms affecting my daily activities.
My treatment for my condition has not changed in the last 6 months.
I have been diagnosed with multiple sclerosis.
My disability level is moderate to severe but I can still walk.
I don't have symptoms affecting my daily activities.
My treatment for my condition has not changed in the last 6 months.
Exclusion Criteria
I have been diagnosed with a neurological condition.
Treatment Details
The study is examining if using Functional Electrical Stimulation (FES) cycling can help manage mobility problems caused by MS better than just passive leg cycling. Participants will be tested to see if this exercise strategy has long-term benefits.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FES Cycling ExerciseExperimental Treatment1 Intervention
FES cycling will involve systematic, transcutaneous electrical stimulation of the leg muscles to produce leg-cycling movement. The intensity and duration of training will be prescribed based on guidelines for aerobic exercise training for persons with MS and from the American College of Sports Medicine, and will progressively increase across 24 weeks. Participants will be encouraged to actively cycle at a minimum cadence of \~40-50 rpm, at 40-60% VO2peak for between 10-50 minutes. The intensity of stimulation will be adjusted per leg muscle group based on sensory tolerance with the goal of maintaining pedaling action and target heart rate over the entire session. At each session, we will record the distance traveled, energy expended, power output, resistance, heart rate and rating of perceived exertion (RPE).
Group II: Passive Leg CyclingPlacebo Group1 Intervention
Passive leg cycling will involve movement of the participant's legs by the cycle ergometer motor without electrical stimulation. The duration of training will follow the same schedule as the FES cycling condition and the same data will be recorded at each session. The passive cycling condition will include the same exposure with the training facility, the exercise equipment (i.e. RT300 cycles), and the research staff (i.e. social contact and attention) as with the FES cycling condition.
FES Cycling Exercise is already approved in United States, Canada, European Union for the following indications:
🇺🇸 Approved in United States as Functional Electrical Stimulation Cycling for:
- Mobility impairment in Multiple Sclerosis
- Rehabilitation for neurological conditions
🇨🇦 Approved in Canada as Functional Electrical Stimulation Cycling for:
- Managing mobility disability in Multiple Sclerosis
- Exercise-based rehabilitation for MS
🇪🇺 Approved in European Union as Functional Electrical Stimulation Cycling for:
- Rehabilitation for neurological conditions including MS
- Improving mobility and reducing muscle atrophy
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of OttawaOttawa, Canada
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Who is running the clinical trial?
University of OttawaLead Sponsor
The Ottawa HospitalCollaborator
Multiple Sclerosis Society of CanadaCollaborator
References
A pilot study of functional electrical stimulation cycling in progressive multiple sclerosis. [2022]Functional electrical stimulation (FES) cycling is used by spinal cord injury patients to facilitate neurologic recovery and may also be useful for progressive MS patients.
Functional electrical stimulation as a component of activity-based restorative therapy may preserve function in persons with multiple sclerosis. [2022]To examine the effect of functional electrical stimulation (FES) cycling on disability progression in persons with multiple sclerosis (MS).
Outcomes After Functional Electrical Stimulation Cycle Training in Individuals with Multiple Sclerosis Who Are Nonambulatory. [2020]Exercise is safe and beneficial for people with multiple sclerosis (MS). Functional electrical stimulation (FES) cycling offers people with significant weakness and mobility challenges an option for exercise. We sought to evaluate the safety of FES cycling and its potential to improve fatigue, pain, spasticity, and quality of life in people with moderate-to-severe MS.
Functional Electrical Stimulation Cycling Exercise for People with Multiple Sclerosis. [2020]There has been substantial interest in the role of exercise for managing impairments, limitations, and disability progression among persons with multiple sclerosis (MS). Despite established benefits of exercise training for persons who have mild-to-moderate MS, the ability to deliver exercise to persons who experience higher disability remains challenging. One promising approach for exercise in this population is functional electrical stimulation (FES) cycling. This review provides a summary of the current evidence for FES cycling as an exercise training modality in persons with MS with respect to prescription, safety, tolerability, and acute and chronic effects.
Functional Electrical Stimulation Cycling Exercise in People with Multiple Sclerosis: Secondary Effects on Cognition, Symptoms, and Quality of Life. [2023]Functional electrical stimulation (FES) cycling is an advanced rehabilitation modality that involves systematic mild electrical stimulation of focal muscle groups to produce leg cycling movement against an adjustable work rate. The present study reports on the efficacy of an assessor-blinded, pilot randomized controlled trial of supervised FES cycling exercise in people with multiple sclerosis (MS) on secondary trial outcomes, including cognition, fatigue, pain, and health-related quality of life.
Effects of Functional Electrical Stimulation Cycling on Fatigue and Quality of Life in People with Multiple Sclerosis Who Are Nonambulatory. [2023]Functional electrical stimulation (FES) cycling provides an exercise opportunity for people with multiple sclerosis (MS) who are nonambulatory. This study evaluated the efficacy of FES cycling for reducing fatigue and improving quality of life in people with MS who are nonambulatory and compared outcomes with those in a control group that did not take part in FES cycling.
Safety and Feasibility of Various Functional Electrical Stimulation Cycling Protocols in Individuals With Multiple Sclerosis Who Are Nonambulatory. [2022]To examine the safety, feasibility, and response to functional electrical stimulation (FES) cycling protocols requiring differing levels of effort in people with multiple sclerosis (MS) who are nonambulatory.