Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of this exploratory study is to evaluate the feasibility and acceptability of the "Active and Mindful" home-based mind-body exercise program for individuals diagnosed with Multiple Sclerosis (MS) in Portugal and Spain.
Multiple Sclerosis often leads to physical and psychological challenges that impact health-related quality of life. Mind-body exercise programs combined with remote supervision present an accessible, flexible alternative to traditional center-based rehabilitation. This study assesses the practicality of implementing a 9-month online intervention delivered via video-conferencing, focusing on recruitment rates, retention, participant attendance, and overall satisfaction. Secondarily, the study explores pre-to-post changes in clinical and psychological indicators such as perceived physical exertion and health-related quality of life.
详细描述
Background:
Multiple Sclerosis (MS) is a chronic, progressive neurological condition that requires ongoing management to maintain physical functioning and psychological well-being. Exercising at home using digital health solutions offers a viable pathway to increase adherence and overcome logistical barriers (such as transportation or geographic isolation) often faced by clinical populations. This exploratory study investigates the "Active and Mindful" program, a remotely supervised, home-based intervention designed specifically to accommodate the functional variations of people living with MS.
Objectives:
- To determine the feasibility of the program through quantitative benchmarks, specifically recruitment efficiency, attrition (retention rate), and global session attendance.
- To evaluate participant acceptability and satisfaction with the synchronous group dynamic.
- To collect preliminary exploratory data on patient-reported outcomes, including perceived exertion during sessions and health-related quality of life domains.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with Multiple Sclerosis living in Portugal or Spain;
- •Expanded Disability Status Scale (EDSS) score below 8;
- •First to register on the online inscription survey (subject to limited spots)
- •Time availability to comply with the session schedules;
- •Access to compatible digital devices with visual feedback (Camera) and reliable internet connectivity;
- •Ability to install and use the ZOOM platform with the camera turned on.
排除标准
- •Significant medical comorbidities that impact or prevent safe exercise participation;
- •Pregnant women.
研究组 & 干预措施
Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program
干预措施: Active and Mindful Program (Other)
结局指标
主要结局
Recruitment Rate
时间窗: Baseline (T0)
Percentage of participants recruited out of the total expressions of interest received.
Retention Rate
时间窗: Post-intervention (T2 - 9 months)
Percentage of participants who completed the intervention and the final follow-up assessments
Global Attendance Rate
时间窗: Through the 9 month intervention
Mean percentage of exercise sessions attended by the participants throughout the program.
Program Satisfaction and Acceptability
时间窗: At the end of every training session throughout the 9-month intervention period.
Participant satisfaction scores measured through a feedback questionnaire (scored on a 1 to 5 Likert scale, where higher scores indicate higher satisfaction).
Perceived Exertion (Borg RPE)
时间窗: At the end of every training session throughout the 9-month intervention period.
Assessment of physical effort intensity during exercise sessions using the Borg Rating of Perceived Exertion (RPE) scale 0-10. Higher scores indicate higher physical exertion.
次要结局
- Hospital Anxiety and Depression Scale (HADS)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- General Health-Related Quality of Life (SF-36)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Multiple Sclerosis-Specific Quality of Life (MSQOL-54)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Modified Fatigue Impact Scale (MFIS)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Activities-Specific Balance Confidence (ABC)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Mindfulness Attention Awareness Scale (MAAS)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Interoceptive Awareness (MAIA)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Physical Activity Levels (IPAQ)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
- Pain Severity and Interference (BPI)(Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months))
研究者
Catarina Alexandra Nunes Martins
Principal Investigator, PhD Student
University of Évora