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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

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.

Last updated: Jul 8, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. 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.

observational

Sarak Kucukosmanoglu H, Aytar A, Bilc MI, Anheyer D, N V Kieninger A, Alaze A, Cramer H · BMJ open (2026)

Participants: N/A
Duration: 8 weeks
Intervention: PhYoMind (PYM) intervention combining specific physical therapy modalities with yoga and mindfulness practices, delivered twice weekly for 75 minutes over 8 weeks, plus a home exercise program
Outcome: Fibromyalgia Impact Questionnaire total score (primary); Central Sensitisation Index, heart rate variability, Visual Analogue Scale for pain, Multidimensional Fatigue Inventory, Perceived Stress Scale, Pittsburgh Sleep Quality Index (secondary)
Effect Size: Cohen's f=0.675
Population: Individuals with a clinical diagnosis of fibromyalgia syndrome (n=40)

Result:

PubMed: 42409395DOI: 10.1136/bmjopen-2026-120248

Mechanism Graph

Physiotherapy modalities reduce musculoskeletal pain and improve physical function
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Yoga and mindfulness practices reduce stress and autonomic dysregulation
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Combined intervention improves central sensitization and sleep quality
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Result: Reduced overall disease impact and functional impairment

Limitations

  • ⚠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.

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References

  1. 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
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.