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FES Cycling for Multiple Sclerosis

N/A

Recruiting

Led By Lara Pilutti, PhD

Research Sponsored by University of Ottawa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Asymptomatic based on a physical activity pre-participation screening tool

Stable course of disease-modifying therapies over the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Awards & highlights

Study Summary

This trial will test whether electrical stimulation can help people with MS manage their mobility impairment, which often gets worse over time.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed, FES Cycling may cause muscle fatigue or discomfort due to electrical stimulation. It's important to note contraindications such as epilepsy where seizures could be triggered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have symptoms affecting my daily activities.

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My treatment for my condition has not changed in the last 6 months.

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I have been diagnosed with multiple sclerosis.

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My disability level is moderate to severe but I can still walk.

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I don't have symptoms affecting my daily activities.

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My treatment for my condition has not changed in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks (mid-point), 24 weeks (immediately post intervention), and 36 weeks (12 weeks follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Walking Speed

Secondary outcome measures

Change in Activities of Daily Living

Change in Agility

Change in Cognitive Performance: Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery

+8 more

Other outcome measures

Change in Body Composition

Change in Cardiorespiratory Fitness

Change in Muscular Fitness

+1 more

Trial Design

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.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

University of OttawaLead Sponsor

207 Previous Clinical Trials

267,101 Total Patients Enrolled

5 Trials studying Multiple Sclerosis

292 Patients Enrolled for Multiple Sclerosis

The Ottawa HospitalOTHER

93 Previous Clinical Trials

62,878 Total Patients Enrolled

3 Trials studying Multiple Sclerosis

147 Patients Enrolled for Multiple Sclerosis

Multiple Sclerosis Society of CanadaOTHER

14 Previous Clinical Trials

961 Total Patients Enrolled

14 Trials studying Multiple Sclerosis

961 Patients Enrolled for Multiple Sclerosis

Media Library

FES Cycling Exercise (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03949387 — N/A

Multiple Sclerosis Research Study Groups: FES Cycling Exercise, Passive Leg Cycling

Multiple Sclerosis Clinical Trial 2023: FES Cycling Exercise Highlights & Side Effects. Trial Name: NCT03949387 — N/A

FES Cycling Exercise (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03949387 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study still enrolling participants?

"Affirmative. According to clinicaltrials.gov, the research was initially posted on October 16th 2019 and recently updated on November 23rd 2022. 40 people are needed from one medical facility for this trial's recruitment process."

Answered by AI

Who is qualified to partake in this medical research?

"The University of Ottawa's clinical study seeks 40 participants who suffer from multiple sclerosis and are aged between 18 and 64. The trial has also set out a list of specific criteria for enrolment, including maintenance on disease-modifying therapies in the past 6 months; absence of relapses over the last 30 days; EDSS score 5.0 - 7.0; an asymptomatic status based on physical activity screening tools; and readiness to attend all testing sessions at University premises."

Answered by AI

Is the age eligibility for this clinical trial confined to those under 25 years of age?

"This trial requires potential participants to be aged 18 or above, yet not older than 64."

Answered by AI

How many applicants is the study enrolling?

"Yes, the relevant information on clinicaltrials.gov confirms that this trial is searching for volunteers. The study was first published on October 16th 2019 and last updated on November 23rd 2022. 40 participants are needed at a single site of recruitment."

Answered by AI