The Effect of Physiotherapy Integrated With Yoga and Mindfulness on Disability in Individuals With Fibromyalgia

NCT ID: NCT07145788

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-07-31

Brief Summary

The current study investigates the effect of an integrative physiotherapy and mind-body programme called PhYoMind on disability 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-based 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, stress, fatigue, and sleep.

Detailed Description

FM is a chronic disorder characterized by widespread pain, fatigue, sleep disturbances, and cognitive-emotional difficulties. Despite its high prevalence, treatment options remain limited and often focus on symptom management rather than addressing underlying physiological dysregulation. Emerging evidence implicates abnormalities in the central nervous system (CNS) and autonomic nervous system (ANS), along with neurochemical imbalances, in the development and persistence of FM symptoms.

Although physiotherapy and mind-body practices such as yoga and mindfulness have individually shown benefits for fibromyalgia symptoms, there is a lack of research on combined interventions integrating these therapies.

The present randomized controlled trial investigates the effects of PhYoMind, a novel integrative program combining physiotherapy techniques - such as Proprioceptive Neuromuscular Facilitation (PNF), Nerve Gliding Exercises (NGE), Mobility Exercises (ME), and Post-Isometric Relaxation (PIR) - with yoga and mindfulness practices. The intervention aims to improve disability and address multiple symptoms in people with FM through an integrated approach.

Participants will be randomly assigned to receive either the PhYoMind program or a home-based stretching, strengthening, and aerobic exercise regimen over 8 weeks. Two supervised sessions per week will be complemented by prescribed home exercises. Outcomes will be assessed at baseline (Week 0) and immediately after post-intervention (Week 8), including disability (primary outcome), as well as pain, stress, fatigue, sleep quality, central nervous system function and autonomic function via heart rate variability.

This study will contribute valuable evidence regarding the potential benefits of an integrative physiotherapy and mind-body approach in managing fibromyalgia symptoms.

Conditions

Fibromyalgia (FM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PhYoMind Intervention Group

Physiotherapy techniques + yoga + mindfulness + home exercise

Group Type: EXPERIMENTAL

PhYoMind

Intervention Type: OTHER

This integrative intervention method includes some specific physiotherapy techniques, ( e. g. self proprioceptive neuromuscular facilitation, self nerve gliding, self mobility, post isometric relaxation techniques) yoga postures, left nostril breathing, humming bee breathing, mindfulness practices and home exercises. Each session will be 75 minutes and focus on different parts of the body and yoga postures will be selected according to these focused areas. For each week, a specific body area will be chosen as the focus. For example, the first week will focus on the hip area and lower extremities, the second week on the upper body and upper extremities, the third week on the core and anterior line of the body, and the fourth week on the back and posterior line of the body and this sequence will continue through the eighth week. In addition to these sessions, participants in this group will also apply home exercises (aerobic+strenghtening+streching) twice a week, 60 minutes per practice.

Home Exercise Group

Only Home Exercise (walking + strenghtening + streching)

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

The control group will receive only home exercises twice a week. Big muscle groups strengthening and stretching exercises and walking planned for the patient will be given as home exercise. The walking exercise will last 30 minutes at a moderately fast pace, depending on the subject's adaptation. The strengthening exercises will last 15 minutes and will consist of 3 sets of 12 repetitions of exercises with body weight and light weights, generally targeting the back extensor muscles, core stabilization muscles, shoulder region muscles in the upper extremity and hip and knee joint muscles in the lower extremity. The stretching exercises will last 15 minutes and will include neck muscles, pectoralis major/minor, erector spina, hamstrings, quadriceps femoris muscles 1-2 times for 30 seconds each. Participants will be taught face to face with a brochure when they come for the first assessment and will be asked to do HE at home.

Interventions

PhYoMind

This integrative intervention method includes some specific physiotherapy techniques, ( e. g. self proprioceptive neuromuscular facilitation, self nerve gliding, self mobility, post isometric relaxation techniques) yoga postures, left nostril breathing, humming bee breathing, mindfulness practices and home exercises. Each session will be 75 minutes and focus on different parts of the body and yoga postures will be selected according to these focused areas. For each week, a specific body area will be chosen as the focus. For example, the first week will focus on the hip area and lower extremities, the second week on the upper body and upper extremities, the third week on the core and anterior line of the body, and the fourth week on the back and posterior line of the body and this sequence will continue through the eighth week. In addition to these sessions, participants in this group will also apply home exercises (aerobic+strenghtening+streching) twice a week, 60 minutes per practice.

Intervention Type: OTHER

Exercise

The control group will receive only home exercises twice a week. Big muscle groups strengthening and stretching exercises and walking planned for the patient will be given as home exercise. The walking exercise will last 30 minutes at a moderately fast pace, depending on the subject's adaptation. The strengthening exercises will last 15 minutes and will consist of 3 sets of 12 repetitions of exercises with body weight and light weights, generally targeting the back extensor muscles, core stabilization muscles, shoulder region muscles in the upper extremity and hip and knee joint muscles in the lower extremity. The stretching exercises will last 15 minutes and will include neck muscles, pectoralis major/minor, erector spina, hamstrings, quadriceps femoris muscles 1-2 times for 30 seconds each. Participants will be taught face to face with a brochure when they come for the first assessment and will be asked to do HE at home.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Presence of clinically diagnosed fibromyalgia according to the American College of Rheumatology

Exclusion Criteria

• Other important causes of pain other than FM
• If participants have hypertension; in case of changes in antihypertensive medication during the study
• Severe osteoarthritis that affects activities of daily living
• Severe somatic or psychiatric disorders
• Receiving another physiotherapy and/or physical exercise treatment concurrently with this study
• Not having sufficient cognitive level or not being able to participate in the sessions.
• Participants must either be on a stable treatment for fibromyalgia or not receiving any treatment, with no intention to alter their treatment plan during the study period. Those who do not meet this criterion will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holger Cramer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of General Practice and Interprofessional Care, University Hospital Tübingen, Tübingen, Germany

Locations

Bosch Health Campus

Stuttgart, Auerbachstraße 112, Germany

Countries

Germany

Central Contacts

Hazal Sarak Kucukosmanoglu, MSc.

Role: CONTACT

Hazal.Sarak@med.uni-tuebingen.de

+4915751203814

Facility Contacts

Hazal Sarak Kucukosmanoglu, MSc.

Role: primary

Hazal.Sarak@med.uni-tuebingen.de

015751203814

Other Identifiers

1059B142400174

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

260/2025BO2

Identifier Type: -

Identifier Source: org_study_id