Exercise Training for People With Advanced Multiple Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aerobic Exercise Training.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development
Overview
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
- 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.
Primary outcome measures
- Feasibility - Recruitment duration [Time frame: Ongoing during the study recruitment period.]
- Feasibility - Recruitment methods [Time frame: Ongoing during the study recruitment period.]
- Feasibility - Recruitment screening time [Time frame: Ongoing during the study recruitment period.]
- Feasibility - Recruitment eligibility rate [Time frame: Ongoing during the study recruitment period.]
- Feasibility - Recruitment exclusion reasons [Time frame: Ongoing during the study recruitment period.]
- Feasibility - Adherence [Time frame: Ongoing during the 12-week intervention.]
- Feasibility - Compliance frequency [Time frame: Ongoing during the 12-week intervention.]
- Feasibility - Compliance duration [Time frame: Ongoing during the 12-week intervention.]
- Feasibility - Compliance intensity [Time frame: Ongoing during the 12-week intervention.]
- Feasibility - Attrition frequency [Time frame: Over the course of the 24-week study period.]
Secondary outcome measures (12)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07546721 · H-11-24-11006 · 1416239