NCT07233902

Brief Summary

This randomized controlled study aims to compare the effects of synchronous and asynchronous exercise programs on individuals diagnosed with relapsing-remitting multiple sclerosis (RRMS). Participants meeting the inclusion criteria (EDSS score between 2 and 5.5, aged 18-55) were randomly assigned to either the Synchronous Exercise Group (SEG) or the Asynchronous Exercise Group (ASEG). The synchronous program was delivered via live online sessions using Google Meet and WhatsApp video calls, while the asynchronous program consisted of pre-recorded exercise videos accessible to participants. Both programs included structured exercises focusing on functional capacity, muscle strength, fatigue, independence, and quality of life. The sample size was determined using G\*Power software based on previous studies in individuals with multiple sclerosis, targeting a total of 16. Statistical analyses will be conducted using SPSS 26.0. Parametric and non-parametric tests will be used depending on data distribution, with significance set at p \< 0.05. The study seeks to improve accessibility to exercise programs for MS patients and provide evidence for the efficacy of remotely delivered synchronous versus asynchronous rehabilitation models.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed
Last Updated

January 21, 2026

Status Verified

November 1, 2025

Enrollment Period

6 months

First QC Date

November 13, 2025

Last Update Submit

January 17, 2026

Conditions

Multiple SclerosisMultiple Sclerosis (MS) - Relapsing-remitting

Keywords

multiple sclerosisonline exercisetele-rehabilitationsynchronousasynchronous

Outcome Measures

Primary Outcomes (5)

  • 6 Minute Walk Test

    The 6-Minute Walk Test is a submaximal functional exercise test used to evaluate aerobic capacity, endurance, and functional mobility in individuals with multiple sclerosis.

    24 weeks

  • Respiratory Muscle Strength

    Respiratory muscle strength is assessed through Maximal Inspiratory Pressure and Maximal Expiratory Pressure measurements obtained with a MicroRPM Pressure Meter. Participants are instructed to place the mouthpiece in their mouth while using a nose clip to prevent air leakage.

    24 weeks

  • Fatigue Severity Scale

    The Fatigue Severity Scale evaluates the impact and severity of fatigue in daily life activities, particularly in individuals with neurological conditions such as multiple sclerosis.

    24 weeks

  • Multiple Sclerosis Quality of Life Scale

    The Multiple Sclerosis Quality of Life Scale is a disease-specific health-related quality of life instrument for individuals with multiple sclerosis. The subscales include physical function, role limitations due to physical problems, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, sexual function, overall quality of life, and satisfaction with sexual function.

    24 weeks

  • Five Times Sit-to-Stand Test

    The Five Times Sit-to-Stand Test is a simple and reliable clinical measure used to assess lower limb muscle strength, functional mobility, and fall risk in individuals with multiple sclerosis.

    24 weeks

Secondary Outcomes (5)

  • Beck Depression Inventory

    24 weeks

  • Beck Anxiety Inventory

    24 weeks

  • Montreal Cognitive Assessment

    24 weeks

  • Berg Balance Scale

    24 weeks

  • Dynamic Gait Index

    24 weeks

Study Arms (2)

Synchronous Exercise Group

EXPERIMENTAL

Participants in this group receives a 12-week structured exercise program delivered synchronously twice per week through live online video sessions (Google Meet or WhatsApp). Each session lasts approximately 40 minutes and included 10 minutes of warm-up, 25 minutes of strengthening and core stabilization exercises, and 5 minutes of cool-down stretching. All sessions are supervised in real time by a physiotherapist. The program focuses on improving functional capacity, muscle strength, fatigue, independence, and quality of life in individuals with relapsing-remitting multiple sclerosis.

Other: Combined Exercise Program (Synchronous Delivery)

Asynchronous Exercise Group

ACTIVE COMPARATOR

Participants in this group receives the same 12-week structured exercise program delivered asynchronously through pre-recorded videos shared online twice per week. Each session lasts approximately 40 minutes, including warm-up, main strengthening/core exercises, and cool-down. Participants maintain exercise logs and reported adherence weekly. Physiotherapists monitor logs and provided feedback via e-mail or phone as needed. The program targets the same outcomes as the synchronous intervention.

Other: Combined Exercise Program (Asynchronous Delivery)

Interventions

Combined Exercise Program (Asynchronous Delivery)OTHER

Participants follow the same 12-week structured exercise program twice weekly using pre-recorded instructional videos. The program consists of warm-up, strengthening/core, and cool-down components identical to the synchronous arm. Participants receive detailed guidance to ensure correct posture and performance, logged each session in exercise diaries, and submitted weekly feedback to researchers. Investigators review exercise logs and provided individualized feedback via e-mail or phone. In case of difficulties, participants can contact the research team for assistance

Asynchronous Exercise Group
Combined Exercise Program (Synchronous Delivery)OTHER

Participants receive a 12-week structured combined exercise program delivered twice weekly via live online video sessions (Google Meet or WhatsApp). Each session lasts approximately 40 minutes and included 10 minutes of warm-up, 25 minutes of strengthening and core stabilization exercises, and 5 minutes of cool-down stretching. Exercise intensity is maintained between 12 and 15 on the Borg Rating of Perceived Exertion scale. Rest periods are adjusted individually. Exercises are supervised in real time by a physiotherapist, who monitored participants' form, safety, and perceived fatigue throughout each session

Synchronous Exercise Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) according to the McDonald criteria.
  • Age between 18 and 55 years.
  • Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5.
  • No relapse within the last six months.
  • Access to the necessary technological infrastructure (internet, camera, and microphone) to participate in the synchronous exercise program.

You may not qualify if:

  • Presence of any neurological diagnosis other than MS.
  • Any vestibular, cardiovascular, or orthopedic condition that limits exercise participation or increases fall risk (Jallouli et al., 2022).
  • Mini-Mental State Examination (MMSE) score below 24.
  • Timed Up and Go (TUG) test result greater than 14.2 seconds, indicating elevated fall risk (Block et al., 2022).
  • Severe visual or auditory impairments.
  • Presence of a psychiatric diagnosis.
  • Current participation in another exercise or physiotherapy/rehabilitation program.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were blinded to group allocation. Participants and intervention providers were aware of group assignments due to the nature of the intervention delivery (synchronous vs asynchronous).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 18, 2025

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 29, 2025

Last Updated

January 21, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared publicly due to ethical and privacy considerations. Group-level results, aggregated data, and summary analyses may be shared upon reasonable request from qualified researchers after publication of the main study findings.

Locations

TU(1)