Exercise Training for People With Advanced Multiple Sclerosis
ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ottawa
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Aerobic Exercise Training
BehavioralModerate 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Aerobic Exercise TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Recruitment duration
Total number of days taken to recruit participants.
Time frame
Ongoing during the study recruitment period.2
Feasibility - Recruitment methods
All methods (types/sources) used to recruit participants.
Time frame
Ongoing during the study recruitment period.3
Feasibility - Recruitment screening time
Time spent screening each participant (minutes).
Time frame
Ongoing during the study recruitment period.4
Feasibility - Recruitment eligibility rate
Percentage of screened individuals who were eligible for study participation.
Time frame
Ongoing during the study recruitment period.Secondary outcomes
1
Cardiorespiratory fitness
Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper
Time frame
Baseline and 12 weeks2
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.
Time frame
Baseline, 6, 12 and 24 weeks3
Function in daily life
Late-Life Function and Disability Instrument (LLFDI). Higher scores indicate greater functional capacity in daily life.
Time frame
Baseline, 6, 12 and 24 weeks4
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.
Time frame
Baseline, 6, 12 and 24 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ottawa
Lead sponsor
Multiple Sclerosis Society of Canada
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: