Exercise Training for People With Advanced Multiple Sclerosis

NCT07546721 | Not Yet Recruiting

• 2 other identifiers: H-11-24-110061416239
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (12)

• Cardiorespiratory fitness

  Baseline and 12 weeks

• Sensory function

  Baseline, 6, 12 and 24 weeks

• Function in daily life

  Baseline, 6, 12 and 24 weeks

• Physical function with a mobility aid

  Baseline, 6, 12 and 24 weeks

• Self-efficacy for managing chronic conditions

  Baseline, 6, 12 and 24 weeks

Study Arms (1)

Aerobic Exercise Training

EXPERIMENTAL

Behavioral: Aerobic Exercise Training

Interventions

Aerobic Exercise Training BEHAVIORAL

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.

Aerobic Exercise Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Ottawa: lead
• Multiple Sclerosis Society of Canada: collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Research Coordinator

CONTACT

613-562-5800; cepl@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share