Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
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.
Detailed Description:
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.
Study:
NCT07233902
Study Brief:
Protocol Section:
NCT07233902