Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Stud… (NCT07654699) | Clinical Trial Compass
CompletedNot Applicable
Active and Mindful - A Mind-Body Programme for People With Multiple Sclerosis: a Feasibility Study Protocol
Portugal50 participantsStarted 2024-03-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate
Timeframe: Baseline (T0)
2
Retention Rate
Timeframe: Post-intervention (T2 - 9 months)
3
Global Attendance Rate
Timeframe: Through the 9 month intervention
4
Program Satisfaction and Acceptability
Timeframe: At the end of every training session throughout the 9-month intervention period.
5
Perceived Exertion (Borg RPE)
Timeframe: At the end of every training session throughout the 9-month intervention period.