protocolSection identificationModule nctId: NCT06298201, orgStudyIdInfo id: IMAGINE2024, briefTitle: E-Based Physical Exercise in Patients With Multiple Sclerosis and Comorbidity, acronym: COMPACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: University of Southern Denmark, class: OTHER, descriptionModule briefSummary: Background: Physical exercise (PE) improves symptoms and quality of life in patients with multiple sclerosis (pwMS). Comorbidity is prevalent among pwMS and may contribute to disease progression. Integrating and sustaining PE is challenging and E-based PE solutions have been proposed as a tool to support the integration of PE into daily life.Aims: To assess the effect of e-based PE in addition to usual care in pwMS on clinical outcome and the levels of inflammatory, metabolic, and neurodegenerative mediators. Furthermore, to determine whether PE plays a role in the modification of comorbidities with a focus on vascular comorbidity and related risk factors, i.e., type 2 diabetes mellitus.Method: This study will be prospective with longitudinal follow-up of pwMS with and without comorbidities. The physical activity of pwMS will be measured at baseline and after six months by accelerometers. In a randomized controlled trial (RCT) patients will be randomly assigned in a 1:1 ratio to receive either usual care or usual care plus an e-based PE program. The exercise program consists of resistance training with resistance bands targeting the lower extremities, including leg press, knee extension, hip flexion, hamstring curl, and hip extension. The sessions will enable participants to engage in group exercises from their homes through a secure online platform, supervised virtually by physiotherapists. The primary endpoints are walking capacity using the 6-meter walk test and the NEDA-3 scale, focusing on the absence of clinical relapses and disease progression, as indicated by an increase in the Expanded Disability Status Scale score and the absence of new disease activity on MRI (including new T2 lesions or enhancing lesions). Secondary outcomes will encompass measures of quality of life and fatigue, as well as levels of potential biomarkers like neurofilament light chain in blood and cerebrospinal fluid.Conclusion: This study will contribute to the rehabilitation and improved quality of life of pwMS particularly of patients with comorbidities. The potential for e-based PE at home to encourage sustained exercise engagement among pwMS will be evaluated, offering a significant contribution to the field of digital healthcare solutions., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial (RCT) with prospective longitudinal follow up, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the intervention, it is not feasible to blind participants or physiotherapists delivering the program. Nonetheless, to preserve the integrity of the trial, outcome assessors (researchers) will remain blinded to the allocation of treatments., whoMasked: PARTICIPANT, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: E-Based Physical Exercise Intervention, outcomesModule primaryOutcomes measure: 6-meters' walk test, primaryOutcomes measure: "no evidence of disease activity" (NEDA-3) score, secondaryOutcomes measure: Cognitive function, evaluated using the Montreal Cognitive Assessment (MoCA),, secondaryOutcomes measure: Fatigue levels, assessed using the short-form Neuro-QOL Fatigue Scale, secondaryOutcomes measure: Neurofilament Light Chain (NfL) determination, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Southern Denmark, status: ENROLLING_BY_INVITATION, city: Odense, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: University of Southern Denmark, status: RECRUITING, city: Odense, zip: 5230, country: Denmark, contacts name: Nasrin Asgari, Professor, role: CONTACT, phone: +4530700612, email: nasgari@health.sdu.dk, contacts name: Ulrik Dalgas, Professor, role: CONTACT, email: dalgas@ph.au.dk, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False