The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia (NCT07145788) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Individuals With Fibromyalgia
Germany40 participantsStarted 2026-02-10
Plain-language summary
The current study investigates the effect of an integrative physiotherapy and mind-body program called PhYoMind intervention on disability and symptoms in individuals with fibromyalgia (FM). Participants will be randomized to either the PhYoMind intervention, which combines specific physiotherapy techniques with yoga and mindfulness, or to a home exercise control group. The intervention lasts 8 weeks, with supervised and home sessions. The primary outcome is disability, with secondary outcomes including measures of central and autonomic nervous system function, pain perception, stress, fatigue, and sleep quality. Adverse events and adherence of the intervention will be also assessed.
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:
* Age ≥ 18 years
* Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology
Exclusion Criteria:
* Other serious illnesses causing severe pain and complicating participation in the study
* Receiving another physiotherapy treatment concurrently with this study
* Regular practice of yoga and/or mindfulness exercises prior to the study
* History of acute myocardial infarction or heart failure and resulting cardiac capacity limitations.
* Uncontrolled hypertension (resting systolic/diastolic blood pressure ≥160/100 mmHg)
* Current treatment with medications known to significantly affect HRV (e.g. beta-blockers or antiarrhythmic drugs)
* Pregnancy or planned pregnancy during the study period
* Severe psychiatric disorders or insufficient cognitive abilities resulting in inability to participate in the study
* Participants must either be on a stable treatment for FMS or not receiving any treatment, with no intention to alter their treatment plan during the study period. (Any unintended changes in fibromyalgia-related medications or other treatments during the study will be recorded and documented).
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.
1This trial combines physiotherapy with yoga and mindfulness for fibromyalgia — given my current level of pain and physical ability, is this kind of integrated approach something my body could realistically handle right now?
2The trial is actively running but no longer enrolling new participants — does that mean there are similar programs or combination approaches already available to me outside of a research setting?
3Since this study is measuring disability and overall fibromyalgia impact using a questionnaire called the FIQ, how does my own FIQ or similar score compare to the kinds of patients who were enrolled, and would that affect whether this type of program makes sense for me?
4This trial doesn't have a traditional phase like a drug study would — does that mean the safety profile of combining physiotherapy, yoga, and mindfulness is already reasonably well understood, or are there still unknowns I should think about?
5Before considering a program like this, would you recommend I try standard physiotherapy or another established treatment on its own first, and how would we know if I was ready to move on to something more integrated?
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.