Mindfulness-Based Yoga for Individuals With Fibromyalgia: A RCT

NCT07439900 | Active Not Recruiting

• 1 other identifier: HU-FTR-2020-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was conducted between March, 2024 and December 30, 2024 to evaluate the effectiveness of an 8-week Mindfulness-Based Yoga (MBY) program in individuals aged 18 years and older who were diagnosed with fibromyalgia. Participants who met the eligibility criteria provided written informed consent prior to enrollment. Eligible participants were randomly assigned in a 1:1 ratio to either the MBY intervention group or the active control group using a simple randomization method based on a lottery draw. The MBY intervention was delivered via telerehabilitation and consisted of structured 75-minute sessions integrating mindfulness practices, breathing exercises, body awareness techniques, and gentle yoga postures. Participants engaged in recorded sessions twice per week and participated in one supervised web-based group session per week led by a trained physiotherapist. The active control group received standard physiotherapy services provided by the hospital and were instructed to perform regular walking exercises. Both groups received education regarding the treatment process at the beginning of the study. Assessments were conducted at baseline and at the end of the 8-week intervention period to evaluate clinical and psychosocial outcomes. This study was registered retrospectively after completion of participant enrollment.

Conditions

Fibromyalgia

Keywords

Mindfulness-Based Yoga; Fibromyalgia; telerehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Fibromyalgia Impact

  Assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR), a validated self-report instrument measuring functional status, overall impact, and symptom severity in individuals with fibromyalgia. Higher scores indicate greater disease impact.

  Baseline and Week 8

Study Arms (2)

Mindfulness-Based Yoga

EXPERIMENTAL

Participants in this arm received an 8-week telerehabilitation-based Mindfulness-Based Yoga program. The intervention included 75-minute sessions integrating breathing exercises, mindfulness practices, body awareness techniques, and gentle yoga postures. Participants completed two recorded sessions per week and one supervised web-based group session per week led by a trained physiotherapist.

Behavioral: Mindfulness-Based Yoga

Active Control (Conventional Physiotherapy)

ACTIVE COMPARATOR

Participants in this arm received 10 sessions of conventional physiotherapy provided by the hospital. In addition, they were instructed to perform 20-minute walking exercises three times per week. Participants were monitored and encouraged through phone or message reminders.

Other: Conventional Physiotherapy

Interventions

Mindfulness-Based Yoga BEHAVIORAL

An 8-week telerehabilitation-based mindfulness yoga program including breathing exercises, body awareness, and gentle yoga postures delivered by a trained physiotherapist.

Also known as: Experimental: Mindfulness-Based Yoga

Mindfulness-Based Yoga

Conventional Physiotherapy OTHER

Ten sessions of conventional physiotherapy combined with prescribed walking exercises performed three times per week.

Active Control (Conventional Physiotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Native Turkish speakers who are literate
• Aged 18 years and older with a confirmed diagnosis of fibromyalgia
• Stable medical treatment for fibromyalgia for the past 3 months
• No planned medication changes during the study period
• Access to a computer, tablet, or smartphone with an active internet connection
• Able to participate in video conferencing independently or with assistance
• Voluntarily agree to participate in the study

You may not qualify if:

• resence of uncontrolled or clinically significant comorbid conditions (e.g., chronic obstructive pulmonary disease, congestive heart failure, endocrine disorders, neurological or significant psychiatric conditions)
• Diagnosis of malignancy
• History of spinal or extremity surgery resulting in functional limitation
• Pregnancy
• Participation in another rehabilitation program
• Any medical or physical condition contraindicating exercise
• Refusal to participate in the study

Sponsors & Collaborators

• Ebru Durusoy: lead

Study Sites (1)

Avcilar Murat Koluk State Hospital

Istanbul, Istanbul, 34100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, participants and care providers were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Msc

Model Details: Participants were randomly assigned using a sealed-envelope method to either the Mindfulness-Based Yoga intervention group or an active control group receiving conventional physiotherapy. Both groups were followed in parallel over an 8-week intervention period.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: March 14, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)