Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol
2026年6月24日 更新者：Catarina Alexandra Nunes Martins
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.
研究概览
详细说明
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:
The study utilized a non-randomized, single-group, interventional design spanning a total duration of 9 months. Individuals with MS were recruited via digital interest forms and institutional channels across Portugal (in collaboration with the Sociedade Portuguesa de Esclerose Múltipla - SPEM) and Spain (in collaboration with the Asociación de Familiares y Afectados de Esclerosis Multiple - AFAEM).
The intervention was structured into distinct functional tiers to ensure physical safety and progressive adaptation:
- Synchronous Phase: Live, exercise sessions conducted via the ZOOM platform in small groups ranging from 3 to 8 participants, organized according to their baseline functional capacity. Sessions were held twice a week and incorporated physical fitness, adapted Pilates, Tai-Chi, mindfulness protocols, and guided relaxation techniques.
- Asynchronous Phase: During the latter half of the program, participants were progressively introduced to and integrated with digital video resources hosted on a dedicated web platform, promoting independent home practice.
- Session Monitoring: To assess the specific feasibility of these pre-recorded video sessions, participants completed study-specific session evaluation forms.
Data collection and Timeline:
Quantitative data and validated health surveys were administered at three distinct time points to capture the progression of the cohort:
- Baseline(T0): Collected before the first exercise session to record sociodemographic characteristics, clinical history, and initial status.
- Midpoint Assessment (T1): Conducted at approximately 4.5 months to monitor early compliance and initial shifts in perceived effort.
- Post-test (T2): Completed at month 9 to evaluate the terminal outcomes, overall compliance, retention metrics, and final system satisfaction.
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Evora、葡萄牙、7000-727
- Departamento de Desporto e Saúde, Escola de Saúde e Desenvolvimento Humano, Universidade de Évora
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Significant medical comorbidities that impact or prevent safe exercise participation;
- Pregnant women.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active and Mindful Mind-Body Exercise Group
People with Multiple Sclerosis participating in a remotely supervised, home-based mind-body exercise program
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An online exercise program (combining synchronous and asynchronous sessions) conducted in a small groups (3 to 8 participants) tailored to functional levels.
Sessions were held twice a week for 9months, including physical fitness, Pilates, Tai-Chi, mindfulness, and relaxation techniques.
In the final phase, asynchronous video resources on a web platform were introduced
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment Rate
大体时间：Baseline (T0)
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Percentage of participants recruited out of the total expressions of interest received.
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Baseline (T0)
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Retention Rate
大体时间：Post-intervention (T2 - 9 months)
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Percentage of participants who completed the intervention and the final follow-up assessments
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Post-intervention (T2 - 9 months)
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Global Attendance Rate
大体时间：Through the 9 month intervention
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Mean percentage of exercise sessions attended by the participants throughout the program.
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Through the 9 month intervention
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Program Satisfaction and Acceptability
大体时间：At the end of every training session throughout the 9-month intervention period.
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Participant satisfaction scores measured through a feedback questionnaire (scored on a 1 to 5 Likert scale, where higher scores indicate higher satisfaction).
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At the end of every training session throughout the 9-month intervention period.
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Perceived Exertion (Borg RPE)
大体时间：At the end of every training session throughout the 9-month intervention period.
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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.
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At the end of every training session throughout the 9-month intervention period.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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General Health-Related Quality of Life (SF-36)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Generic health status questionnaire covering 8 domains.
Subscale scores range from 0 to 100, where higher scores indicate better health status and quality of life.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Multiple Sclerosis-Specific Quality of Life (MSQOL-54)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Evaluation of MS-specific quality of life across physical and mental health composites.
Scores range from 0 to 100, where higher scores represent superior quality of life.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Modified Fatigue Impact Scale (MFIS)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Assessment of the impact of fatigue on physical, cognitive, and psychosocial functioning using the Modified Fatigue Impact Scale (MFIS).
Total score ranges from 0 to 84, where higher scores indicate a greater negative impact of fatigue.
Scores above 38 indicate significant clinical fatigue.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Activities-Specific Balance Confidence (ABC)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Self-reported scale measuring a patient's confidence in maintaining balance during various daily ambulatory activities.
Scores range from 0% to 100%, where higher percentages indicate greater balance confidence.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Mindfulness Attention Awareness Scale (MAAS)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Assessment of mindful presence and awareness in daily life using the Mindful Attention Awareness Scale (MAAS).
Total score ranges from 1 to 6 (calculated as a mean of items), where higher scores indicate higher dispositional mindfulness.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Interoceptive Awareness (MAIA)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Evaluation of body awareness and connection through the Multidimensional Assessment of Interoceptive Awareness (MAIA).
It measures 8 subscales scored from 0 to 5, with higher scores indicating better interoceptive awareness and body trusting.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Physical Activity Levels (IPAQ)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Assessment of total physical activity over the previous 7 days using the International Physical Activity Questionnaire (IPAQ).
Outcomes are reported as continuous scores in MET-minutes/week or categorized into Low, Moderate, or High activity groups.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Pain Severity and Interference (BPI)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Evaluation of pain intensity and its impact on daily functional activities using the Brief Pain Inventory (BPI).
It generates two major subscales: Pain Severity (0-10) and Pain Interference (0-10), where higher scores denote worse pain and higher functional impairment.
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Hospital Anxiety and Depression Scale (HADS)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Evaluation of psychological distress using the Hospital Anxiety and Depression Scale (HADS), comprising two subscales: Anxiety (HADS-A) and Depression (HADS-D).
Each subscale scores from 0 to 21, where higher scores indicate greater severity of symptoms (worse outcome).
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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State Mindfulness Scale (SMS)
大体时间：Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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Measurement of state mindfulness experienced during or immediately after intervention sessions using the State Mindfulness Scale.
The SMS is a 21-item self-report measure with a 5-point Likert-type scale (1 = not at all to 5 = very well), comprising two subscales: State Mindfulness of Mind (15 items) and State Mindfulness of Body (6 items).
Total scores range from 21 to 105, where higher scores reflect greater state mindfulness (better outcome).
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Baseline (T0), Midpoint (T1 - 4.5 months), and Post-intervention (T2 - 9 months)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年3月1日
初级完成 (实际的)
2025年4月1日
研究完成 (实际的)
2025年4月1日
研究注册日期
首次提交
2026年6月12日
首先提交符合 QC 标准的
2026年6月12日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.