Multiple Sclerosis
Conditions
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.
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.
Interventions
BEHAVIORALAerobic 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.
Sponsors
University of Ottawa
Multiple Sclerosis Society of Canada
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Recruitment duration | Ongoing during the study recruitment period. | Total number of days taken to recruit participants. |
| Feasibility - Recruitment methods | Ongoing during the study recruitment period. | All methods (types/sources) used to recruit participants. |
| Feasibility - Recruitment screening time | Ongoing during the study recruitment period. | Time spent screening each participant (minutes). |
| Feasibility - Recruitment eligibility rate | Ongoing during the study recruitment period. | Percentage of screened individuals who were eligible for study participation. |
| Feasibility - Recruitment exclusion reasons | Ongoing during the study recruitment period. | Frequency of exclusion criteria recorded during eligibility screening. |
| Feasibility - Adherence | Ongoing during the 12-week intervention. | Total number of sessions attended out of a possible 24. |
| Feasibility - Compliance frequency | 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 | 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 | Ongoing during the 12-week intervention. | Extent to which each participant followed the prescribed exercise protocol in terms of intensity. |
| Feasibility - Attrition frequency | Over the course of the 24-week study period. | Total number of participants who dropped out of the study before completion. |
| Feasibility - Attrition reasons | Over the course of the 24-week study period. | Reasons for participant dropout (if applicable). |
| Feasibility - Time required for testing sessions | 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 | Ongoing during the 12-week intervention. | Total time spent collecting, entering and checking training data per training session. |
| Feasibility - Personnel required | Over the course of the 24-week study period. | Ratio of participants to personnel (researchers) per testing and training session. |
| Feasibility - Personnel training completed | 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 | Before the start of the trial. | Time taken from submission to full approval of study protocol. |
| Feasibility - Adverse events | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory fitness | Baseline and 12 weeks | Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper |
| Sensory function | Baseline, 6, 12 and 24 weeks | Functional Systems Score (FSS) for the sensory system within the Expanded Disability Status Scale (EDSS) clinical examination. Higher scores indicate greater sensory impairment. |
| Function in daily life | Baseline, 6, 12 and 24 weeks | Late-Life Function and Disability Instrument (LLFDI). Higher scores indicate greater functional capacity in daily life. |
| Physical function with a mobility aid | Baseline, 6, 12 and 24 weeks | Short Form Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function with Mobility Aid questionnaire. Higher scores indicate greater physical function. |
| Self-efficacy for managing chronic conditions | Baseline, 6, 12 and 24 weeks | 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. |
| Symptoms of fatigue | Baseline, 6, 12 and 24 weeks | Modified Fatigue Impact Scale (MFIS) questionnaire. Higher scores indicate a greater impact of fatigue in daily life. |
| Symptoms of pain | Baseline, 6, 12 and 24 weeks | Short-Form McGill Pain Questionnaire (SF-MPQ). Higher scores indicate greater pain. |
| Cognitive performance | Baseline, 6, 12 and 24 weeks | Stroop Color and Word Test |
| Participant experiences of the intervention | After the 12-week intervention. | Participant experiences of taking part in the exercise program will be explored through qualitative, semi-structured exit interviews. |
| Participant-reported outcomes related to the intervention | Baseline and 12 weeks. | 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. |
Contacts
CONTACTResearch Coordinator
Outcome results
None listed