Exercise Training for People With Advanced Multiple Sclerosis

Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development

The goal of this interventional study is to test the feasibility of 12 weeks of aerobic exercise for people with advanced multiple sclerosis (i.e., wheelchair users). The main questions it aims to answer are:

• Is the exercise intervention feasible in terms of study processes, resources, management, safety, and acceptability?
• Can the intervention improve aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, and sensation?
• What are participants' experiences of taking part in the exercise intervention?

Participants will take part in moderate-intensity aerobic exercise twice a week for 12 weeks in a supervised research setting. Outcomes will be measured at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-weeks after the intervention (24 weeks). The outcomes include feasibility measures, aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation, and participant experiences of taking part in the exercise intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Aerobic Exercise Training

Detailed Description

Multiple sclerosis (MS) is a neurodegenerative disorder that results in the progressive accumulation of disability. Disability accumulation in MS is associated with the loss of physiological fitness, particularly cardiorespiratory fitness (CRF; i.e., the ability of the body to transport and use oxygen during activity). In MS, low CRF has been associated with worse motor and cognitive performance, symptoms, brain structure and plasticity, body composition, quality of life, and participation in daily activities. This emphasizes the need for treatment options that focus on the preservation of CRF.

Non-pharmacological approaches, such as exercise, are an essential component of comprehensive disease management in MS. Exercise training has been associated with numerous benefits in MS, including improvements in CRF and other fitness outcomes, mobility, symptoms, health-related quality of life, and participation in everyday activities. These benefits have primarily been established in people with MS who have mild-to-moderate disability levels (i.e., Expanded Disability Status Scale [EDSS] scores ≤ 6.5). As a result, the role of exercise for people with advanced MS (EDSS ≥ 7.0) is largely unknown.

This study aims to investigate the feasibility of aerobic exercise training for people living with advanced MS (i.e., EDSS ≥ 7.0). Participants will engage in moderate-intensity aerobic exercise (i.e., recumbent stepper, total body ergometer, and/or functional electrical stimulation leg cycle) twice a week for 12 weeks. Outcomes will be assessed at baseline (0 weeks), mid-intervention (6 weeks), post-intervention (12 weeks), and 12-week follow-up (24 weeks). The outcome assessments include feasibility measures, efficacy outcomes (aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, sensation), and participant experiences of taking part in the exercise intervention.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 3274 613-562-5800; Email: cepl@uottawa.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥18 years of age
• Self-reported diagnosis of MS
• Expanded Disability Status Score ≥ 7.0
• Stable course of disease-modifying therapy over past six months
• Physician approval for exercise participation

Exclusion Criteria:

• Diagnosis of other neurological conditions
• Relapse within 30 days
• Signs or symptoms of acute or uncontrolled cardiovascular, renal or metabolic disease or other conditions that make it unsafe to exercise
• Currently engaging in regular aerobic exercise (≥ 2 sessions/week for ≥ 12 weeks)
• Additional exclusion criteria for functional electrical stimulation (FES) cycling exercise are cardiac demand pacemakers, implanted defibrillators, unhealed fractures, pregnancy, epilepsy, autonomic dysreflexia, and acute infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Aerobic Exercise Training

Behavioral: Aerobic Exercise Training; Moderate intensity (40-59% heart rate reserve) aerobic exercise using a recumbent stepper, total body ergometer, and/or functional electrical stimulation leg cycle. Sessions will be delivered twice per week for up to 40 minutes per session for 12 weeks (i.e., up to 24 sessions total). Exercise will be prescribed based on individual fitness testing results and participant preferences, with progression in intensity and duration over 12-weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment duration	Total number of days taken to recruit participants.	Ongoing during the study recruitment period.
Feasibility - Recruitment methods	All methods (types/sources) used to recruit participants.	Ongoing during the study recruitment period.
Feasibility - Recruitment screening time	Time spent screening each participant (minutes).	Ongoing during the study recruitment period.
Feasibility - Recruitment eligibility rate	Percentage of screened individuals who were eligible for study participation.	Ongoing during the study recruitment period.
Feasibility - Recruitment exclusion reasons	Frequency of exclusion criteria recorded during eligibility screening.	Ongoing during the study recruitment period.
Feasibility - Adherence	Total number of sessions attended out of a possible 24.	Ongoing during the 12-week intervention.
Feasibility - Compliance frequency	Extent to which each participant followed the prescribed exercise protocol in terms of frequency (sessions/week).	Ongoing during the 12-week intervention.
Feasibility - Compliance duration	Extent to which each participant followed the prescribed exercise protocol in terms of duration (minutes/session).	Ongoing during the 12-week intervention.
Feasibility - Compliance intensity	Extent to which each participant followed the prescribed exercise protocol in terms of intensity.	Ongoing during the 12-week intervention.
Feasibility - Attrition frequency	Total number of participants who dropped out of the study before completion.	Over the course of the 24-week study period.
Feasibility - Attrition reasons	Reasons for participant dropout (if applicable).	Over the course of the 24-week study period.
Feasibility - Time required for testing sessions	Total time spent collecting, entering, checking, and processing outcome data per testing time point.	At each testing timepoint (Baseline, 6, 12, and 24 weeks).
Feasibility - Time required for training sessions	Total time spent collecting, entering and checking training data per training session.	Ongoing during the 12-week intervention.
Feasibility - Personnel required	Ratio of participants to personnel (researchers) per testing and training session.	Over the course of the 24-week study period.
Feasibility - Personnel training completed	Number and type of training activities completed by study personnel before starting the intervention.	Before delivery of the 12-week intervention.
Feasibility - Time required for research ethics approval	Time taken from submission to full approval of study protocol.	Before the start of the trial.
Feasibility - Adverse events	Number, type, and timing of adverse events.	Over the course of the 24-week study period (recorded at each testing and training session).
Feasibility - Acceptability of equipment	Participant feedback on equipment enjoyment, confidence in equipment use, perceived fitness benefits of the equipment, and recommendations and expected use of the equipment in community exercise settings.	After the 12-week intervention.
Feasibility - Acceptability of outcomes	Assessor feedback on what went well during outcome testing, specific challenges encountered, the timing of outcome delivery, and suggestions for improvement.	At each testing timepoint (Baseline, 6, 12 and 24 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness	Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper	Baseline and 12 weeks
Sensory function	Functional Systems Score (FSS) for the sensory system within the Expanded Disability Status Scale (EDSS) clinical examination. Higher scores indicate greater sensory impairment.	Baseline, 6, 12 and 24 weeks
Function in daily life	Late-Life Function and Disability Instrument (LLFDI). Higher scores indicate greater functional capacity in daily life.	Baseline, 6, 12 and 24 weeks
Physical function with a mobility aid	Short Form Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function with Mobility Aid questionnaire. Higher scores indicate greater physical function.	Baseline, 6, 12 and 24 weeks
Self-efficacy for managing chronic conditions	Short Form Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions questionnaire. Higher scores indicate greater confidence in managing chronic health conditions.	Baseline, 6, 12 and 24 weeks
Symptoms of fatigue	Modified Fatigue Impact Scale (MFIS) questionnaire. Higher scores indicate a greater impact of fatigue in daily life.	Baseline, 6, 12 and 24 weeks
Symptoms of pain	Short-Form McGill Pain Questionnaire (SF-MPQ). Higher scores indicate greater pain.	Baseline, 6, 12 and 24 weeks
Cognitive performance	Stroop Color and Word Test	Baseline, 6, 12 and 24 weeks
Cognitive performance	Symbol Digit Modalities Test	Baseline and 12 weeks
Cognitive performance	Paced Auditory Serial Addition Test	Baseline and 12 weeks
Participant experiences of the intervention	Participant experiences of taking part in the exercise program will be explored through qualitative, semi-structured exit interviews.	After the 12-week intervention.
Participant-reported outcomes related to the intervention	Participant expected and observed outcomes related to the intervention will be explored through an importance-rating worksheet activity. Higher scores reflect greater importance of outcomes in daily life.	Baseline and 12 weeks.

Collaborators and Investigators

• Sponsor: University of Ottawa
• Collaborators: Multiple Sclerosis Society of Canada

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: H-11-24-11006; 1416239 (Other Grant/Funding Number: Multiple Sclerosis Canada)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No