PhYoMind intervention (physiotherapy-integrated yoga and mindfulness) plus home exercise improves disease impact and functional impairment in fibromyalgia syndrome compared to home exercise alone
This protocol describes an 8-week randomized controlled trial (n=40) comparing PhYoMind (physiotherapy, yoga, and mindfulness) plus home exercise versus home exercise alone in individuals with fibromyalgia syndrome. The primary outcome is the Fibromyalgia Impact Questionnaire total score, with secondary outcomes including sleep quality, pain, fatigue, and autonomic function. The study is powered at 80% with an effect size of Cohen's f=0.675.
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PhYoMind intervention (physiotherapy-integrated yoga and mindfulness) plus home exercise improves disease impact and functional impairment in fibromyalgia syndrome compared to home exercise alone The current body of evidence comprises 1 study, including 1 randomized controlled trial. EvidenceHub rates the overall confidence at 44/100 (low).
The Claim
PhYoMind intervention (physiotherapy-integrated yoga and mindfulness) plus home exercise improves disease impact and functional impairment in fibromyalgia syndrome compared to home exercise alone
This conclusion is most relevant to: Individuals with a clinical diagnosis of fibromyalgia syndrome (n=40).
What the Research Shows
The conclusion draws on 1 linked study. Highlights from the cited literature:
- ▸Physiotherapy-integrated yoga and mindfulness plus home exercise versus home exercise alone for individuals with fibromyalgia syndrome (PhYoMind): study protocol of a randomised controlled clinical trial. (BMJ open, 2026) —
How It Works
The proposed biological pathway:
- ▸Physiotherapy modalities reduce musculoskeletal pain and improve physical function
- ▸Yoga and mindfulness practices reduce stress and autonomic dysregulation
- ▸Combined intervention improves central sensitization and sleep quality
- ▸Result: Reduced overall disease impact and functional impairment
Who Might Benefit
Evidence fit by population:
- ▸Individuals with a clinical diagnosis of fibromyalgia syndrome (n=40)
Recommended Dose
N/A
Limitations & Caveats
Important context when interpreting this evidence:
- ▸This is a study protocol, not results; no efficacy data are yet available
- ▸Small sample size (n=40) may limit generalizability
- ▸Monocentric design may reduce external validity
Frequently Asked Questions
What is the PhYoMind intervention?▼
PhYoMind is a multimodal integrative protocol combining specific physical therapy modalities with yoga and mindfulness practices, delivered twice weekly for 75 minutes over 8 weeks, in addition to a home exercise program.
How is sleep quality measured in this study?▼
Sleep quality is assessed as a secondary outcome using the Pittsburgh Sleep Quality Index (PSQI).
Who is eligible for this trial?▼
Individuals with a clinical diagnosis of fibromyalgia syndrome (FMS) are eligible; the study aims to recruit 40 participants.
What is the primary outcome of the trial?▼
The primary outcome is the broad disease impact and functional impairments measured by the total score of the Fibromyalgia Impact Questionnaire.
References
- 1.Sarak Kucukosmanoglu H, Aytar A, Bilc MI, Anheyer D, N V Kieninger A, Alaze A, Cramer H. “Physiotherapy-integrated yoga and mindfulness plus home exercise versus home exercise alone for individuals with fibromyalgia syndrome (PhYoMind): study protocol of a randomised controlled clinical trial..” BMJ open, 2026. PMID: 42409395 DOI: 10.1136/bmjopen-2026-120248