NCT Number: NCT07546721
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Ongoing during the study recruitment period.
Total number of days taken to recruit participants.
Time frame: Ongoing during the study recruitment period.
All methods (types/sources) used to recruit participants.
Time frame: Ongoing during the study recruitment period.
Time spent screening each participant (minutes).
Time frame: Ongoing during the study recruitment period.
Percentage of screened individuals who were eligible for study participation.
Time frame: Ongoing during the study recruitment period.
Frequency of exclusion criteria recorded during eligibility screening.
Time frame: Ongoing during the 12-week intervention.
Total number of sessions attended out of a possible 24.
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of frequency (sessions/week).
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of duration (minutes/session).
Time frame: Ongoing during the 12-week intervention.
Extent to which each participant followed the prescribed exercise protocol in terms of intensity.
Time frame: Over the course of the 24-week study period.
Total number of participants who dropped out of the study before completion.
Time frame: Over the course of the 24-week study period.
Reasons for participant dropout (if applicable).
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.
Time frame: Ongoing during the 12-week intervention.
Total time spent collecting, entering and checking training data per training session.
Time frame: Over the course of the 24-week study period.
Ratio of participants to personnel (researchers) per testing and training session.
Time frame: Before delivery of the 12-week intervention.
Number and type of training activities completed by study personnel before starting the intervention.
Time frame: Before the start of the trial.
Time taken from submission to full approval of study protocol.
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.
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.
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.
Time frame: Baseline and 12 weeks
Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper
Time frame: 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.
Time frame: Baseline, 6, 12 and 24 weeks
Late-Life Function and Disability Instrument (LLFDI). Higher scores indicate greater functional capacity in daily life.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12 and 24 weeks
Modified Fatigue Impact Scale (MFIS) questionnaire. Higher scores indicate a greater impact of fatigue in daily life.
Time frame: Baseline, 6, 12 and 24 weeks
Short-Form McGill Pain Questionnaire (SF-MPQ). Higher scores indicate greater pain.
Time frame: Baseline, 6, 12 and 24 weeks
Stroop Color and Word Test
Time frame: Baseline and 12 weeks
Symbol Digit Modalities Test
Time frame: Baseline and 12 weeks
Paced Auditory Serial Addition Test
Time frame: After the 12-week intervention.
Participant experiences of taking part in the exercise program will be explored through qualitative, semi-structured exit interviews.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
University of Ottawa
Other
Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development
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