An interventional study of Mobility-Intensive Qigong Exercise and Static Posture-Based Qigong Exercise in Fibromyalgia, sponsored by Saglik Bilimleri Universitesi. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Saglik Bilimleri Universitesi · Not applicable, Interventional, and Treatment
This randomized controlled pilot study investigates the comparative efficacy of mobility-intensive Qigong exercises versus static posture-based Qigong exercises in patients diagnosed with fibromyalgia. Participants are randomly allocated to either a mobility-intensive Qigong intervention group or a static posture-based Qigong intervention group. The primary objectives are to evaluate improvements in spinal mobility and reductions in pain levels. Secondary outcomes include enhancements in functional exercise capacity, reductions in fatigue severity, and improvements in health-related quality of life. All outcome assessments are conducted at baseline and upon completion of the intervention program.
Study Rationale and Design:
Fibromyalgia is a chronic musculoskeletal condition characterized by widespread pain, debilitating fatigue, and reduced physical functioning, frequently accompanied by marked limitations in spinal mobility. Mind-body movement modalities such as Qigong demonstrate potential in fibromyalgia rehabilitation; however, comparative evidence elucidating the specific efficacy of dynamic mobility-oriented movement sets versus static posture-based regimens remains sparse.
This study is designed as a double-blind (participants and outcome assessors), two-arm randomized controlled pilot trial. A total of 36 female participants meeting the 2010 American College of Rheumatology (ACR) diagnostic criteria are allocated in a 1:1 ratio using computer-generated simple randomization to one of two active interventions: Mobility-Intensive Qigong (Group 1) or Static Posture-Based Qigong (Group 2). Participants are informed that the trial compares two gentle therapeutic exercise programs to maintain participant blinding, while data analysts and outcome assessors remain fully blinded to group allocation.
Sample Size Determination:
The sample size estimation was determined using Hamidiye Ethics Committee Biostatistics Guidelines and relevant literature referencing pain reduction (McGill Pain Questionnaire) with an effect size of Cohen's d = 1.26. Given the comparison of two active interventions, an anticipated large effect size of d = 1.0 was selected. Setting alpha at 0.05 and statistical power at 80% yielded a minimum required sample of 33 participants. To ensure equal distribution across groups and accommodate potential dropouts, the target sample was finalized at 36 participants.
Intervention Protocol:
Both interventions are delivered online under the live supervision of an experienced physiotherapist and certified Qigong instructor over 12 consecutive weeks (2 sessions per week, 45 minutes per session). Each session comprises 5 minutes of structured warm-up and participant check-in, followed by 40 minutes of protocol-specific Qigong exercises. Group 1 performs dynamic, flowing movements focusing on active multi-segmental joint mobility, muscle lengthening, and breath coordination. Group 2 focuses on sustained isometric postures, focused breath regulation, and static stretching to build postural stability and endurance. Participants who miss a live session are provided structured home-practice guidance; an adherence rate of at least 90% is required for per-protocol analysis.
Assessment Protocol and Settings:
Face-to-face outcome evaluations are carried out at baseline (prior to session 1) and post-intervention at the Akdeniz University Department of Physical Medicine and Rehabilitation in a standardized, climate-controlled setting. Each assessment requires approximately 45 minutes per subject.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 36 is below the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive dynamic and fluid mobility-intensive Qigong exercises focusing on active range of motion, muscle flexibility, muscle strengthening, and breath coordination under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
Other: Mobility-Intensive Qigong Exercise
Participants receive static posture-based Qigong exercises consisting of sustained isometric postures, breath regulation, and alignment control to enhance postural stability, static endurance, and core strengthening under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
Other: Static Posture-Based Qigong Exercise
Dynamic and fluid mobility-intensive Qigong exercises focusing on active range of motion, muscle flexibility, muscle strengthening, and breath coordination under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
Participants receive static posture-based Qigong exercises consisting of sustained isometric postures, breath regulation, and alignment control to enhance postural stability, static endurance, and core strengthening under online physiotherapist supervision (12 weeks, 2 sessions/week, 45 minutes/session).
Change in Pain Intensity Measured by Visual Analog Scale (VAS)
Pain intensity is evaluated using a 100-mm Visual Analog Scale (VAS), where 0 mm indicates "no pain" and 100 mm indicates "unbearable pain." Participants mark their perceived pain intensity on a horizontal 100-mm line. Higher scores represent greater pain severity. Changes from baseline to the end of the 12-week intervention are assessed.
Time frame: Baseline and post-intervention at Week 12
Change in Pain Dimensions Assessed by Short-Form McGill Pain Questionnaire (SF-MPQ)
Qualitative and sensory/affective pain dimensions are evaluated using the Short-Form McGill Pain Questionnaire (SF-MPQ). It consists of 15 descriptors (11 sensory, 4 affective) scored on a 4-point intensity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total score ranges from 0 to 45. Higher scores indicate greater pain severity. Changes from baseline to Week 12 are assessed.
Time frame: Baseline and post-intervention at Week 12
Change in Spinal Mobility Measured by Inclinometer
Spinal range of motion is evaluated objectively across cervical, thoracic, and lumbar segments (flexion, extension, and lateral flexion) using a digital/bubble inclinometer. Measurements are recorded in degrees (°). Higher values indicate greater range of motion and improved spinal mobility. Changes from baseline to Week 12 post-intervention are assessed.
Time frame: Baseline and post-intervention at Week 12
Change in Fatigue Severity Assessed by Fatigue Severity Scale (FSS)
Fatigue severity and its impact on daily activities are evaluated using the 9-item self-report Fatigue Severity Scale (FSS). Items are rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). The total score represents the mean of all items (range: 1 to 7). Higher scores indicate more severe fatigue. Changes from baseline to Week 12 are assessed.
Time frame: Baseline and post-intervention at Week 12
Change in Disease Impact and Quality of Life Measured by Revised Fibromyalgia Impact Questionnaire (FIQR)
Disease severity, symptom impact, and health-related quality of life are assessed using the Revised Fibromyalgia Impact Questionnaire (FIQR). The questionnaire comprises 21 questions across three domains (function, overall impact, symptoms) scored on an 11-point numeric scale (0 to 10). The total score ranges from 0 to 100, where higher scores reflect greater disease burden and poorer quality of life. Changes from baseline to Week 12 are assessed.
Time frame: Baseline and post-intervention at Week 12
Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)
Submaximal functional exercise capacity is assessed using the 6-Minute Walk Test (6MWT) administered in accordance with the 2022 American Thoracic Society (ATS) technical standards. The total distance walked in meters during 6 minutes is recorded. A longer distance indicates better functional physical capacity. Changes from baseline to Week 12 are assessed.
Time frame: Baseline and post-intervention at Week 12
Plan to share: No — Individual participant data will not be shared in order to protect participant confidentiality and comply with local ethical committee guidelines and personal data protection regulations.
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