MS Synchronous vs Asynchronous Exercise Study

NCT ID: NCT07233902

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-29

Brief Summary

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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.

Detailed Description

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This randomized controlled trial was designed to evaluate and compare the effects of synchronous and asynchronous structured exercise programs in individuals diagnosed with relapsing-remitting multiple sclerosis (RRMS). The main aim was to investigate differences in fatigue, functional exercise capacity, muscle strength, functional independence, and quality of life between the two intervention models.

Participants were recruited according to the inclusion criteria: age 18-55, RRMS diagnosis according to McDonald criteria, Expanded Disability Status Scale (EDSS) score between 2 and 5.5, no relapse within the last six months, and access to technological infrastructure (internet, camera, microphone). Exclusion criteria included other neurological diagnoses, cardiovascular, vestibular, or orthopedic conditions limiting exercise participation, cognitive impairment (Mini-Mental State Examination \<24), fall risk (Timed Up and Go \>14.2 s), psychiatric disorders, vision or hearing impairments, pregnancy, or concurrent physiotherapy programs.

Participants were randomly assigned into two groups (n=20 each): the Synchronous Exercise Group (SEG) and the Asynchronous Exercise Group (ASEG). Both groups performed a 12-week combined exercise program (2 sessions per week, 40 minutes per session) consisting of strengthening, core stabilization, and respiratory exercises, followed by a 3-month follow-up period. The structured program included warm-up (10 min: rhythmic stepping, diaphragmatic breathing, shoulder mobility), main exercises (25 min: bridging, plank, squats, seated upper-limb strengthening), and cool-down (5 min: stretching and relaxation).

The synchronous group performed exercises live through Google Meet or WhatsApp video calls under real-time physiotherapist supervision. The asynchronous group followed pre-recorded video sessions and submitted exercise logs weekly; feedback and follow-up were provided via e-mail or phone.

Assessments were conducted at four time points: baseline (D0), mid-intervention (4th week; D1), post-intervention (12th week; D2), and after a 3-month follow-up (D3). Statistical analyses were performed using SPSS 26.0; normality was assessed via the Kolmogorov-Smirnov test. Within-group comparisons used paired-sample t tests or Wilcoxon tests, and between-group differences were analyzed using independent t tests or Mann-Whitney U tests. Repeated-measures ANOVA was applied for follow-up analyses, with significance set at p \< 0.05.

The study hypothesized that synchronous telerehabilitation would result in superior outcomes compared to asynchronous exercise delivery in terms of fatigue reduction, muscle strength improvement, and enhanced functional capacity.

Conditions

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Multiple Sclerosis Multiple Sclerosis (MS) - Relapsing-remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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).

Study Groups

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Synchronous Exercise Group

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.

Group Type EXPERIMENTAL

Combined Exercise Program (Synchronous Delivery)

Intervention Type 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

Asynchronous Exercise Group

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.

Group Type ACTIVE_COMPARATOR

Combined Exercise Program (Asynchronous Delivery)

Intervention Type 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

Interventions

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Combined Exercise Program (Synchronous Delivery)

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

Intervention Type OTHER

Combined Exercise Program (Asynchronous Delivery)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yeditepe University

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TUBITAK 1002-A 125S054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

YEDITEPE-MS-SYNCASYNC-2025

Identifier Type: -

Identifier Source: org_study_id

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