[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656763":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":41,"studyPopulation":29,"armGroups":42,"interventions":55,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":88,"collaborators":29,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":29,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":29,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":29,"overallStatus":111,"whyStopped":29,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Saglik Bilimleri Universitesi","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Baseline and post-intervention at Week 12",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in Pain Dimensions Assessed by Short-Form McGill Pain Questionnaire (SF-MPQ)","Qualitative and sensory\u002Faffective 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.",{"measure":18,"description":19,"timeFrame":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\u002Fbubble 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.",{"measure":21,"description":22,"timeFrame":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.",{"measure":24,"description":25,"timeFrame":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.",{"measure":27,"description":28,"timeFrame":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.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","A two-arm parallel randomized controlled trial comparing mobility-intensive Qigong against static posture-based Qigong.","TREATMENT",{"masking":36,"maskingDescription":37,"whoMasked":38},"DOUBLE","Participants are blinded by presenting the study as a comparison between two gentle therapeutic exercise programs without disclosing experimental designations. Outcome assessors conducting face-to-face evaluations and data analysts remain blinded to group allocations throughout the trial.",[39,40],"PARTICIPANT","OUTCOMES_ASSESSOR","Study Rationale and Design:\n\nFibromyalgia 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.\n\nThis 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.\n\nSample Size Determination:\n\nThe 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.\n\nIntervention Protocol:\n\nBoth 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.\n\nAssessment Protocol and Settings:\n\nFace-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.\n\n* Primary Clinical Endpoints: Pain intensity and characteristics are quantified using the Short-Form McGill Pain Questionnaire (SF-MPQ, sensory and affective subscales) and a 100-mm Visual Analog Scale (VAS). Spinal mobility across cervical, thoracic, and lumbar segments (flexion, extension, lateral flexion) is measured objectively using an inclinometer.\n* Secondary Clinical Endpoints: Functional exercise capacity is measured using the submaximal 6-Minute Walk Test (6MWT) performed strictly according to 2022 American Thoracic Society (ATS) technical standards. Fatigue severity is assessed via the 9-item Fatigue Severity Scale (FSS), and overall disease-specific functional impact is measured with the Revised Fibromyalgia Impact Questionnaire (FIQR).",[43,49],{"label":44,"type":45,"description":46,"interventionNames":47},"Group 1: Mobility-Intensive Qigong","EXPERIMENTAL","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\u002Fweek, 45 minutes\u002Fsession).",[48],"Other: Mobility-Intensive Qigong Exercise",{"label":50,"type":51,"description":52,"interventionNames":53},"Static Posture-Based Qigong","ACTIVE_COMPARATOR","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\u002Fweek, 45 minutes\u002Fsession).",[54],"Other: Static Posture-Based Qigong Exercise",[56,60],{"type":6,"name":57,"description":58,"armGroupLabels":59,"otherNames":29},"Mobility-Intensive 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\u002Fweek, 45 minutes\u002Fsession).",[44],{"type":6,"name":61,"description":52,"armGroupLabels":62,"otherNames":29},"Static Posture-Based Qigong Exercise",[50],[64],{"name":65,"affiliation":5,"role":66},"DEFNE KAYA UTLU, Prof. Dr.","STUDY_DIRECTOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":29,"email":72},"MERYEM AKSARI GEDİKLİ, PT, MSc, PhD(c)","CONTACT","+90 531 208 15 15","aksarimeryem@gmail.com",[74],{"facility":75,"status":29,"city":76,"state":29,"zip":77,"country":78,"countryCode":29,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Akdeniz University Hospital, Department of Physical Medicine and Rehabilitation","Antalya","07070","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],30.69556,36.90812,{"lat":83,"lon":82},[86],{"name":87,"role":70,"phone":71,"phoneExt":29,"email":72},"Meryem Aksarı Gedikli, PT, MSc, PhD(c)",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Meryem Aksarı Gedikli","Physical Therapist, PhD Candidate","100656763","qigong-intervention-for-fibromyalgia-a-randomized-controlled-study-100656763",false,"NCT07830186","Qigong Intervention for Fibromyalgia","Qigong Intervention for Fibromyalgia: Improving Spinal Mobility in Fibromyalgia Patients: A Randomized Controlled Pilot Study","Inclusion Criteria:\n\n* Female patients aged between 30 and 50 years.\n* Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology (ACR) criteria.\n* Non-obese, defined as Body Mass Index (BMI) \\\u003C 30 kg\u002Fm².\n* Lack of clinical improvement despite receiving pharmacological treatment for more than 3 months.\n* Willingness to adhere to the 12-week supervised online exercise program.\n\nExclusion Criteria:\n\n* Pregnancy or currently breastfeeding.\n* Presence of advanced musculoskeletal pathologies (e.g., inflammatory arthritis, severe osteoarthritis).\n* Diagnosed neurological disorders or peripheral neuropathy.\n* Known severe cardiovascular diseases.\n* History of surgical intervention within the past 4 months.\n* Participation in any regular physical exercise or rehabilitation program within the past 2 months prior to enrollment.","FEMALE","30 Years","50 Years",{"count":103,"type":104},36,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.",[110],"Fibromyalgia","NOT_YET_RECRUITING","2026-09-21",{"date":114,"type":115},"2026-09-24","ACTUAL",{"date":117,"type":104},"2026-10-15",{"date":119,"type":104},"2027-01-21",{"name":5,"class":6},1]