[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634979":3},{"organization":4,"outcomesModule":7,"designInfo":114,"detailedDescription":120,"studyPopulation":113,"armGroups":121,"interventions":127,"overallOfficials":113,"centralContacts":132,"locations":113,"responsibleParty":139,"collaborators":141,"id":144,"slug":113,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":113,"eligibilityCriteria":149,"healthyVolunteers":145,"sex":150,"minAge":151,"maxAge":113,"enrollmentInfo":152,"targetDuration":113,"studyType":155,"phases":156,"briefSummary":157,"conditions":158,"keywords":113,"overallStatus":160,"whyStopped":113,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":113},{"fullName":5,"class":6},"University of Ottawa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":75,"otherOutcomes":113},[9,13,16,19,22,25,29,32,35,38,42,45,49,52,55,59,63,67,71],{"measure":10,"description":11,"timeFrame":12},"Feasibility - Recruitment duration","Total number of days taken to recruit participants.","Ongoing during the study recruitment period.",{"measure":14,"description":15,"timeFrame":12},"Feasibility - Recruitment methods","All methods (types\u002Fsources) used to recruit participants.",{"measure":17,"description":18,"timeFrame":12},"Feasibility - Recruitment screening time","Time spent screening each participant (minutes).",{"measure":20,"description":21,"timeFrame":12},"Feasibility - Recruitment eligibility rate","Percentage of screened individuals who were eligible for study participation.",{"measure":23,"description":24,"timeFrame":12},"Feasibility - Recruitment exclusion reasons","Frequency of exclusion criteria recorded during eligibility screening.",{"measure":26,"description":27,"timeFrame":28},"Feasibility - Adherence","Total number of sessions attended out of a possible 24.","Ongoing during the 12-week intervention.",{"measure":30,"description":31,"timeFrame":28},"Feasibility - Compliance frequency","Extent to which each participant followed the prescribed exercise protocol in terms of frequency (sessions\u002Fweek).",{"measure":33,"description":34,"timeFrame":28},"Feasibility - Compliance duration","Extent to which each participant followed the prescribed exercise protocol in terms of duration (minutes\u002Fsession).",{"measure":36,"description":37,"timeFrame":28},"Feasibility - Compliance intensity","Extent to which each participant followed the prescribed exercise protocol in terms of intensity.",{"measure":39,"description":40,"timeFrame":41},"Feasibility - Attrition frequency","Total number of participants who dropped out of the study before completion.","Over the course of the 24-week study period.",{"measure":43,"description":44,"timeFrame":41},"Feasibility - Attrition reasons","Reasons for participant dropout (if applicable).",{"measure":46,"description":47,"timeFrame":48},"Feasibility - Time required for testing sessions","Total time spent collecting, entering, checking, and processing outcome data per testing time point.","At each testing timepoint (Baseline, 6, 12, and 24 weeks).",{"measure":50,"description":51,"timeFrame":28},"Feasibility - Time required for training sessions","Total time spent collecting, entering and checking training data per training session.",{"measure":53,"description":54,"timeFrame":41},"Feasibility - Personnel required","Ratio of participants to personnel (researchers) per testing and training session.",{"measure":56,"description":57,"timeFrame":58},"Feasibility - Personnel training completed","Number and type of training activities completed by study personnel before starting the intervention.","Before delivery of the 12-week intervention.",{"measure":60,"description":61,"timeFrame":62},"Feasibility - Time required for research ethics approval","Time taken from submission to full approval of study protocol.","Before the start of the trial.",{"measure":64,"description":65,"timeFrame":66},"Feasibility - Adverse events","Number, type, and timing of adverse events.","Over the course of the 24-week study period (recorded at each testing and training session).",{"measure":68,"description":69,"timeFrame":70},"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.","After the 12-week intervention.",{"measure":72,"description":73,"timeFrame":74},"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.","At each testing timepoint (Baseline, 6, 12 and 24 weeks).",[76,80,84,87,90,93,96,99,102,104,106,109],{"measure":77,"description":78,"timeFrame":79},"Cardiorespiratory fitness","Peak volume of oxygen uptake (VO2peak) achieved during a cardiopulmonary exercise test on a recumbent stepper","Baseline and 12 weeks",{"measure":81,"description":82,"timeFrame":83},"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.","Baseline, 6, 12 and 24 weeks",{"measure":85,"description":86,"timeFrame":83},"Function in daily life","Late-Life Function and Disability Instrument (LLFDI). Higher scores indicate greater functional capacity in daily life.",{"measure":88,"description":89,"timeFrame":83},"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.",{"measure":91,"description":92,"timeFrame":83},"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.",{"measure":94,"description":95,"timeFrame":83},"Symptoms of fatigue","Modified Fatigue Impact Scale (MFIS) questionnaire. Higher scores indicate a greater impact of fatigue in daily life.",{"measure":97,"description":98,"timeFrame":83},"Symptoms of pain","Short-Form McGill Pain Questionnaire (SF-MPQ). Higher scores indicate greater pain.",{"measure":100,"description":101,"timeFrame":83},"Cognitive performance","Stroop Color and Word Test",{"measure":100,"description":103,"timeFrame":79},"Symbol Digit Modalities Test",{"measure":100,"description":105,"timeFrame":79},"Paced Auditory Serial Addition Test",{"measure":107,"description":108,"timeFrame":70},"Participant experiences of the intervention","Participant experiences of taking part in the exercise program will be explored through qualitative, semi-structured exit interviews.",{"measure":110,"description":111,"timeFrame":112},"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.","Baseline and 12 weeks.",null,{"allocation":115,"interventionModel":116,"interventionModelDescription":113,"primaryPurpose":117,"observationalModel":113,"timePerspective":113,"maskingInfo":118},"NA","SINGLE_GROUP","TREATMENT",{"masking":119,"maskingDescription":113,"whoMasked":113},"NONE","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.\n\nNon-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.\n\nThis 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\u002For 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.",[122],{"label":123,"type":124,"description":113,"interventionNames":125},"Aerobic Exercise Training","EXPERIMENTAL",[126],"Behavioral: Aerobic Exercise Training",[128],{"type":129,"name":123,"description":130,"armGroupLabels":131,"otherNames":113},"BEHAVIORAL","Moderate intensity (40-59% heart rate reserve) aerobic exercise using a recumbent stepper, total body ergometer, and\u002For 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.",[123],[133],{"name":134,"role":135,"phone":136,"phoneExt":137,"email":138},"Research Coordinator","CONTACT","613-562-5800","3274","cepl@uottawa.ca",{"type":140,"investigatorFullName":113,"investigatorTitle":113,"investigatorAffiliation":113,"oldNameTitle":113,"oldOrganization":113},"SPONSOR",[142],{"name":143,"class":6},"Multiple Sclerosis Society of Canada","100634979",false,"NCT07546721","Exercise Training for People With Advanced Multiple Sclerosis","Exercise Training for People With Advanced Multiple Sclerosis: A Feasibility Study to Inform Intervention Development","Inclusion Criteria:\n\n* ≥18 years of age\n* Self-reported diagnosis of MS\n* Expanded Disability Status Score ≥ 7.0\n* Stable course of disease-modifying therapy over past six months\n* Physician approval for exercise participation\n\nExclusion Criteria:\n\n* Diagnosis of other neurological conditions\n* Relapse within 30 days\n* Signs or symptoms of acute or uncontrolled cardiovascular, renal or metabolic disease or other conditions that make it unsafe to exercise\n* Currently engaging in regular aerobic exercise (≥ 2 sessions\u002Fweek for ≥ 12 weeks)\n* 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","ALL","18 Years",{"count":153,"type":154},12,"ESTIMATED","INTERVENTIONAL",[115],"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:\n\n* Is the exercise intervention feasible in terms of study processes, resources, management, safety, and acceptability?\n* Can the intervention improve aerobic fitness, function in daily life, cognition, symptoms of fatigue and pain, and sensation?\n* What are participants' experiences of taking part in the exercise intervention?\n\nParticipants 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.",[159],"Multiple Sclerosis","NOT_YET_RECRUITING","2026-04-16",{"date":163,"type":164},"2026-04-23","ACTUAL",{"date":166,"type":154},"2026-05-01",{"date":168,"type":154},"2027-06-01",{"name":5,"class":6}]