Multiple SclerosisNCT07546721
Exercise Training for People With Advanced Multiple Sclerosis
A study testing Aerobic Exercise Training in people with Multiple Sclerosis, run by University of Ottawa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Aerobic Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Aerobic Exercise Training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Training | Experimental | Not described Receives: Behavioral: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Recruitment duration
Total number of days taken to recruit participants.
Measured: Ongoing during the study recruitment period.
Feasibility - Recruitment methods
All methods (types/sources) used to recruit participants.
Measured: Ongoing during the study recruitment period.
Feasibility - Recruitment screening time
Time spent screening each participant (minutes).
Measured: Ongoing during the study recruitment period.
Feasibility - Recruitment eligibility rate
Percentage of screened individuals who were eligible for study participation.
Measured: Ongoing during the study recruitment period.
Feasibility - Recruitment exclusion reasons
Frequency of exclusion criteria recorded during eligibility screening.
Measured: Ongoing during the study recruitment period.
Feasibility - Adherence
Total number of sessions attended out of a possible 24.
Measured: 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).
Measured: 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).
Measured: Ongoing during the 12-week intervention.
Feasibility - Compliance intensity
Extent to which each participant followed the prescribed exercise protocol in terms of intensity.
Measured: Ongoing during the 12-week intervention.
Feasibility - Attrition frequency
Total number of participants who dropped out of the study before completion.
Measured: Over the course of the 24-week study period.
Feasibility - Attrition reasons
Reasons for participant dropout (if applicable).
Measured: 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.
Measured: 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.
Measured: Ongoing during the 12-week intervention.
Feasibility - Personnel required
Ratio of participants to personnel (researchers) per testing and training session.
Measured: 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.
Measured: Before delivery of the 12-week intervention.
Feasibility - Time required for research ethics approval
Time taken from submission to full approval of study protocol.
Measured: Before the start of the trial.
Feasibility - Adverse events
Number, type, and timing of adverse events.
Measured: 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.
Measured: 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.
Measured: At each testing timepoint (Baseline, 6, 12 and 24 weeks).
Secondary outcomes (12)
Cardiorespiratory fitness
Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6, 12 and 24 weeks
Symptoms of pain
Short-Form McGill Pain Questionnaire (SF-MPQ). Higher scores indicate greater pain.
Measured: Baseline, 6, 12 and 24 weeks
Cognitive performance
Stroop Color and Word Test
Measured: Baseline, 6, 12 and 24 weeks
Cognitive performance
Symbol Digit Modalities Test
Measured: Baseline and 12 weeks
Cognitive performance
Paced Auditory Serial Addition Test
Measured: 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.
Measured: 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.
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546721
- Sponsor's protocol ID
- H-11-24-11006
- Other IDs
- 1416239
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development
- ClinicalTrials.gov ID
- NCT07546721
- Acronym / sponsor ID
- H-11-24-11006
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Training | Experimental | Behavioral: Aerobic Exercise Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise TrainingModerate 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. | Behavioural | Aerobic Exercise Training |
Primary outcome
Feasibility - Recruitment duration
Time frame: Ongoing during the study recruitment period.
Total number of days taken to recruit participants.
Feasibility - Recruitment methods
Time frame: Ongoing during the study recruitment period.
All methods (types/sources) used to recruit participants.
Feasibility - Recruitment screening time
Time frame: Ongoing during the study recruitment period.
Time spent screening each participant (minutes).
Feasibility - Recruitment eligibility rate
Time frame: Ongoing during the study recruitment period.
Percentage of screened individuals who were eligible for study participation.
Feasibility - Recruitment exclusion reasons
Time frame: Ongoing during the study recruitment period.
Frequency of exclusion criteria recorded during eligibility screening.
Feasibility - Adherence
Time frame: Ongoing during the 12-week intervention.
Total number of sessions attended out of a possible 24.
Feasibility - Compliance frequency
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of frequency (sessions/week).
Feasibility - Compliance duration
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of duration (minutes/session).
Feasibility - Compliance intensity
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of intensity.
Feasibility - Attrition frequency
Time frame: Over the course of the 24-week study period.
Total number of participants who dropped out of the study before completion.
Feasibility - Attrition reasons
Time frame: Over the course of the 24-week study period.
Reasons for participant dropout (if applicable).
Feasibility - Time required for testing sessions
Time frame: At each testing timepoint (Baseline, 6, 12, and 24 weeks).
Total time spent collecting, entering, checking, and processing outcome data per testing time point.
Feasibility - Time required for training sessions
Time frame: Ongoing during the 12-week intervention.
Total time spent collecting, entering and checking training data per training session.
Feasibility - Personnel required
Time frame: Over the course of the 24-week study period.
Ratio of participants to personnel (researchers) per testing and training session.
Feasibility - Personnel training completed
Time frame: Before delivery of the 12-week intervention.
Number and type of training activities completed by study personnel before starting the intervention.
Feasibility - Time required for research ethics approval
Time frame: Before the start of the trial.
Time taken from submission to full approval of study protocol.
Feasibility - Adverse events
Time frame: Over the course of the 24-week study period (recorded at each testing and training session).
Number, type, and timing of adverse events.
Feasibility - Acceptability of equipment
Time frame: After the 12-week intervention.
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.
Feasibility - Acceptability of outcomes
Time frame: At each testing timepoint (Baseline, 6, 12 and 24 weeks).
Assessor feedback on what went well during outcome testing, specific challenges encountered, the timing of outcome delivery, and suggestions for improvement.
12 secondary outcomes
Cardiorespiratory fitness
Time frame: Baseline and 12 weeks
Sensory function
Time frame: Baseline, 6, 12 and 24 weeks
Function in daily life
Time frame: Baseline, 6, 12 and 24 weeks
Physical function with a mobility aid
Time frame: Baseline, 6, 12 and 24 weeks
Self-efficacy for managing chronic conditions
Time frame: Baseline, 6, 12 and 24 weeks
Symptoms of fatigue
Time frame: Baseline, 6, 12 and 24 weeks
Symptoms of pain
Time frame: Baseline, 6, 12 and 24 weeks
Cognitive performance
Time frame: Baseline, 6, 12 and 24 weeks
Cognitive performance
Time frame: Baseline and 12 weeks
Cognitive performance
Time frame: Baseline and 12 weeks
Participant experiences of the intervention
Time frame: After the 12-week intervention.
Participant-reported outcomes related to the intervention
Time frame: Baseline and 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training in people with Multiple Sclerosis, run by University of Ottawa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (613-562-5800 ext. 3274, cepl@uottawa.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment duration (time frame: Ongoing during the study recruitment period.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.