Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:12 AM
Study NCT ID:
NCT07424859
Status:
COMPLETED
Last Update Posted:
2026-02-24
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Yoga and Conventional Physical Exercise for Pain and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D004414', 'term': 'Dyspareunia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015013', 'term': 'Yoga'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The yoga program consisted of eight 30-minute sessions delivered once weekly via Zoom or Google Meet. Sessions included an initial brief meditation, followed by pranayama techniques (e.g., Prana Shuddhi, Chandra Bhedana, Bhramari) and postures such as Sukhasana, Paschimottanasana, Gomukhasana, Baddha Konasana, Tadasana, Adho Mukha Svanasana, Anjaneyasana and Eka Pada Rajakapotasana, ending with Savasana. Participants were advised not to engage in other structured physical activity during the intervention period; Participants assigned to the physical exercise arm received eight weekly 30-minute online group sessions focusing on functional strengthening and stretching of the hip and pelvis, delivered via videoconference by physical educators or physiotherapists.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-16', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dysmenorrhea intensity (VAS 0-10)', 'timeFrame': 'Baseline to week 8', 'description': 'Difference in dysmenorrhea intensity measured on a 0-10 visual analogue scale (VAS), comparing yoga and physical exercise groups. Higher scores indicate more intense pain.'}, {'measure': 'Change in dysmenorrhea intensity (VAS 0-10)', 'timeFrame': 'Baseline (week 0) to week 8', 'description': 'Difference in dysmenorrhea intensity measured on a 0-10 visual analogue scale (VAS), comparing yoga and physical exercise groups. Higher scores indicate more intense pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Chronic Pain', 'Dysmenorrhea', 'Dyspareunia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Murayama BAR, Mello PLP, Valdívia MS, et al. Evaluation of yoga in controlling pain symptoms and quality of life in women with endometriosis: a randomized clinical trial. Journal of Integrative Gynecology. 2026;15(2):123-135.'}]}, 'descriptionModule': {'briefSummary': 'two-arm randomized parallel-group trial comparing an 8-week online yoga program versus a conventional physical exercise program.', 'detailedDescription': 'Study Design\n\nStudy Type Interventional (Clinical Trial)\n\nPrimary Purpose Treatment\n\nAllocation Randomized\n\nIntervention Model Parallel Assignment\n\nMasking None (Open Label)\n\nNumber of Arms 2\n\nInterventional Study Model Description (opcional) Two-arm randomized parallel-group trial comparing an 8-week online yoga program versus a conventional physical exercise program.\n\n4\\. Conditions and Keywords\n\nCondition Endometriosis\n\nKeywords\n\nEndometriosis\n\nChronic pelvic pain\n\nDysmenorrhea\n\nDyspareunia\n\nYoga\n\nPhysical exercise\n\nQuality of life\n\n5\\. Arms and Interventions Arm 1\n\nArm Type Experimental\n\nArm Name Yoga\n\nArm Description Participants assigned to the yoga arm received eight weekly 30-minute online group sessions delivered via videoconference by trained instructors. Each session included meditation, pranayama breathing techniques and a standardized sequence of seated and standing postures targeting relaxation, body awareness, flexibility and pelvic/lumbopelvic muscle balance.\n\nIntervention Type Other\n\nIntervention Name Yoga program\n\nIntervention Description The yoga program consisted of eight 30-minute sessions delivered once weekly via Zoom or Google Meet. Sessions included an initial brief meditation, followed by pranayama techniques (e.g., Prana Shuddhi, Chandra Bhedana, Bhramari) and postures such as Sukhasana, Paschimottanasana, Gomukhasana, Baddha Konasana, Tadasana, Adho Mukha Svanasana, Anjaneyasana and Eka Pada Rajakapotasana, ending with Savasana. Participants were advised not to engage in other structured physical activity during the intervention period.\n\nArm 2\n\nArm Type Active Comparator\n\nArm Name Conventional Physical Exercise\n\nArm Description Participants assigned to the physical exercise arm received eight weekly 30-minute online group sessions focusing on functional strengthening and stretching of the hip and pelvis, delivered via videoconference by physical educators or physiotherapists.\n\nIntervention Type Other\n\nIntervention Name Conventional physical exercise program\n\nIntervention Description The physical exercise program consisted of eight 30-minute sessions delivered once weekly via Zoom or Google Meet. Each session included four modules: 8 minutes of hip and lumbopelvic warm-up, 8 minutes of bodyweight squats, 8 minutes of strengthening exercises for hip and pelvic stabilizers (gluteus medius, gluteus maximus, tensor fasciae latae, piriformis, adductors/abductors), and 6 minutes of stretching to improve flexibility and muscle relaxation.\n\n6\\. Outcome Measures Primary Outcome Measures\n\nUse um desfecho primário claro (o artigo trata dor como foco principal). Exemplo:\n\nChange in dysmenorrhea intensity (VAS 0-10)\n\nTime Frame: Baseline (week 0) to week 8\n\nDescription: Difference in dysmenorrhea intensity measured on a 0-10 visual analogue scale (VAS), comparing yoga and physical exercise groups. Higher scores indicate more intense pain.\n\nChange in deep dyspareunia intensity (VAS 0-10)\n\nTime Frame: Baseline to week 8\n\nDescription: Difference in deep dyspareunia intensity measured on a 0-10 VAS, comparing yoga and physical exercise groups.\n\nChange in non-cyclical pelvic pain intensity (VAS 0-10)\n\nTime Frame: Baseline to week 8\n\nDescription: Difference in acyclical pelvic pain intensity measured on a 0-10 VAS, comparing yoga and physical exercise groups.\n\n(Se o PRS exigir 1 primário apenas, escolha só dysmenorrhea VAS como Primary e marque os outros como Secondary.) Secondary Outcome Measures\n\nChange in cyclic bowel symptom intensity (VAS 0-10)\n\nTime Frame: Baseline to week 8\n\nDescription: Change in intensity of cyclic bowel symptoms/dyschezia on a 0-10 VAS.\n\nChange in cyclic urinary symptom intensity (VAS 0-10)\n\nTime Frame: Baseline to week 8\n\nDescription: Change in intensity of cyclic urinary symptoms/dysuria on a 0-10 VAS.\n\nChange in SF-36 domain scores\n\nTime Frame: Baseline to week 8\n\nDescription: Change in eight domains of the Short-Form 36 (functional capacity, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, mental health). Higher scores indicate better quality of life.\n\nChange in EHP-30 domain scores\n\nTime Frame: Baseline to week 8\n\nDescription: Change in domains of the Endometriosis Health Profile-30 (pain, control, emotional well-being, social support, self-image, work, sexual relations, medical care, treatment, infertility). Higher scores indicate worse health status.\n\nPatient satisfaction with the intervention (Likert scale)\n\nTime Frame: Week 8\n\nDescription: Overall satisfaction with the assigned intervention assessed on a Likert scale questionnaire (e.g., very dissatisfied to very satisfied).\n\nAdherence to the intervention protocol\n\nTime Frame: 8 weeks\n\nDescription: Proportion of participants who attended all eight scheduled sessions; reasons for non-adherence (scheduling conflicts, non-response, medical or personal reasons).\n\n7\\. Eligibility Criteria\n\nInclusion Criteria\n\nWomen aged 18 to 45 years\n\nConfirmed diagnosis of endometriosis by pelvic magnetic resonance imaging, transvaginal ultrasound with bowel preparation, or laparoscopy with histological confirmation\n\nPresence of endometriosis-related pain (dysmenorrhea, deep dyspareunia, non-cyclical pelvic pain, dyschezia, or cyclical dysuria) with minimum intensity ≥3 on a 0-10 scale\n\nAbility to participate in online sessions via videoconference\n\nProvision of written informed consent\n\nExclusion Criteria\n\nActive malignancy\n\nKnown infectious or inflammatory disease\n\nContraindications to practicing physical activity\n\nScheduled surgery during the 8-week study period\n\nInitiation of new hormonal therapy during the study period\n\nAge older than 45 years\n\nRefusal or inability to provide informed consent\n\nSex/Gender: Female\n\nAge Limits: 18 Years to 45 Years\n\nAccepts Healthy Volunteers: No\n\n8\\. Locations and Contacts\n\nCountries of Recruitment Brazil\n\nFacility 1\n\nName: Hospital BP - A Beneficência Portuguesa de São Paulo\n\nCity: São Paulo\n\nCountry: Brazil\n\nFacility 2\n\nName: Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo (HCFMUSP)\n\nCity: São Paulo\n\nCountry: Brazil\n\nOverall Official / Principal Investigator\n\nName: Maurício Simões Abrão, MD\n\nAffiliation: Faculdade de Medicina da Universidade de São Paulo\n\n9\\. Oversight / Ethics\n\nHuman Subjects Review Approved\n\nIRB / Ethics Committee Name Research Ethics Committee of BP - Beneficência Portuguesa de São Paulo and the Endometriosis Outpatient Clinic of HCFMUSP\n\nEthics Approval Number 6.310.906'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18 to 45 years\n* Confirmed diagnosis of endometriosis by pelvic magnetic resonance imaging, transvaginal ultrasound with bowel preparation, or laparoscopy with histological confirmation\n* Presence of endometriosis-related pain (dysmenorrhea, deep dyspareunia, non-cyclical pelvic pain, dyschezia, or cyclical dysuria) with minimum intensity ≥3 on a 0-10 scale\n* Ability to participate in online sessions via videoconference\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Active malignancy\n* Known infectious or inflammatory disease\n* Contraindications to practicing physical activity\n* Scheduled surgery during the 8-week study period\n* Initiation of new hormonal therapy during the study period\n* Age older than 45 years\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07424859', 'briefTitle': 'Evaluation of Yoga and Conventional Physical Exercise for Pain and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Beneficência Portuguesa de São Paulo'}, 'officialTitle': 'Evaluation of Yoga in Controlling Pain Symptoms and Quality of Life in Women With Endometriosis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '17755'}, 'secondaryIdInfos': [{'id': '198728884', 'type': 'OTHER', 'domain': 'beneficiencia portuguesa de são paulo'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 yoga', 'description': 'Participants assigned to the yoga arm received eight weekly 30-minute online group sessions delivered via videoconference by trained instructors. Each session included meditation, pranayama breathing techniques and a standardized sequence of seated and standing postures targeting relaxation, body awareness, flexibility and pelvic/lumbopelvic muscle balance', 'interventionNames': ['Other: YOGA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'arm 2 - physical exercise', 'description': 'Participants assigned to the physical exercise arm received eight weekly 30-minute online group sessions focusing on functional strengthening and stretching of the hip and pelvis, delivered via videoconference by physical educators or physiotherapists.', 'interventionNames': ['Other: physical exercise']}], 'interventions': [{'name': 'YOGA', 'type': 'OTHER', 'description': 'The Yoga program incorporated meditation, pranayama breathing techniques, and physical postures aimed at relaxation, body awareness, and improvement of flexibility and muscle balance', 'armGroupLabels': ['Arm 1 yoga']}, {'name': 'physical exercise', 'type': 'OTHER', 'description': 'The physical exercise protocol included joint warm-up, strengthening and stabilization exercises for the pelvis and hip, and stretching for mobility and muscle relief, focusing primarily on functional and resistance-based movements rather than aerobic or traditional weight-training components', 'armGroupLabels': ['arm 2 - physical exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01323001', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Beneficencia Portuguesa de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beneficência Portuguesa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD', 'investigatorFullName': 'Marina de Paula Andres Amaral', 'investigatorAffiliation': 'Beneficência Portuguesa de São Paulo'}}}}