Comparison of the Effects of Synchronous and Asynchronous Exercise Programs in Individuals With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •No relapse within the last six months.
- •Access to the necessary technological infrastructure (internet, camera, and microphone) to participate in the synchronous exercise program.
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Combined Exercise Program (Synchronous Delivery) (Other)
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.
干预措施: Combined Exercise Program (Asynchronous Delivery) (Other)
结局指标
主要结局
6 Minute Walk Test
时间窗: 24 weeks
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.
Five Times Sit-to-Stand Test
时间窗: 24 weeks
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.
Respiratory Muscle Strength
时间窗: 24 weeks
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.
Fatigue Severity Scale
时间窗: 24 weeks
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.
Multiple Sclerosis Quality of Life Scale
时间窗: 24 weeks
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.
次要结局
- Montreal Cognitive Assessment(24 weeks)
- Dynamic Gait Index(24 weeks)
- Beck Depression Inventory(24 weeks)
- Beck Anxiety Inventory(24 weeks)
- Berg Balance Scale(24 weeks)