Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-01 @ 3:34 PM
Study NCT ID:
NCT06750393
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Effects of Barre and Gym Ball Exercises in Primary Dysmenorhoea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-20', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2024-12-20', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numeric Pain rating Scale', 'timeFrame': '12th week', 'description': 'Numeric pain rating scale is a subjective measure 11 point numerical scale which is used to measure pain. Is scoring range In this scale 0 shows no pain and 10 shows worst pain imaginable. It has good reliability of 0.79 and validity of 0.96.'}, {'measure': 'Menstrual distress questionnaire (MEDI-Q):', 'timeFrame': '12th week', 'description': 'The Menstrual Distress Questionnaire (MEDI-Q) is a newly developed tool that has been validated for comprehensive evaluation of menstrual-related distress .It consists of 25 items that cover different areas of menstruation-related symptoms, such as pain, discomfort, psychic or cognitive changes, and gastrointestinal disturbances. In this scale 0 -16 score indicates Mild symptoms, indicating minimal distress,17-34 indicates Moderate symptoms, indicating moderate distress.35-56 indicates Severe symptoms. It is reliable tool with reliability 0.84 and validity 0.95.'}, {'measure': 'Quality Of Life Enjoyment And Satisfaction Questionnaire Short Form(Q-LESQ-SF)', 'timeFrame': '12th week', 'description': 'Short-Form (Q-LES-Q-SF) was derived from the general activities scale of the original 93- item questionnaire. It consists of 16 items but only 14 item scores are computed, the last two are stand-alone items. Q-LES-Q-SF is rated on a 5-point scale as 1-very poor, 2-poor, 3-fair, 4-good, and 5-very good. 70 is the maximum score. It is a reliable and valid tool with values 0.9 and 0.93.'}, {'measure': 'WaLLiD Score', 'timeFrame': '12th week', 'description': 'WaLLiD score was designed to diagnose dysmenorrhea and predict medical leave score as a standard survey that validated and constructed the classification of the severity of dysmenorrhea. The interpretation of the WaLLiD questionnaire is as follows: 0 = No dysmenorrhea 1-4 =Mild dysmenorrhea 5-7 = Moderate dysmenorrhea 8-12 = Severe dysmenorrhea WaLLiD score is reliable tool with value of 0.723'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gym', 'exercises', 'quality of life', 'dysmenorrhea', 'Menstrual Cycle', 'female'], 'conditions': ['Dysmenorrhea Primary']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Samperio MM, Pardo ACJMSR. Efectos del ejercicio físico en la dismenorrea primaria. Revisión sistemática. 2021;1(1).'}, {'type': 'BACKGROUND', 'citation': 'Azabu A, Fernandes P, Thomas T. Effect Of a Gym Ball Exercise Program on Dysmenorrhea in Nursing Students of a Selected College in Mangaluru, India: A Quasi experimental Study. gums-hnmj. 2024;34(1):29-34'}, {'pmid': '34360122', 'type': 'BACKGROUND', 'citation': 'Lopez-Liria R, Torres-Alamo L, Vega-Ramirez FA, Garcia-Luengo AV, Aguilar-Parra JM, Trigueros-Ramos R, Rocamora-Perez P. Efficacy of Physiotherapy Treatment in Primary Dysmenorrhea: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021 Jul 23;18(15):7832. doi: 10.3390/ijerph18157832.'}, {'type': 'BACKGROUND', 'citation': '.Krasova I, Semyzorova A, Deineko A, Beihul I, Shyshkina OJPR, Technologies RH. Barre fitness as a modern means of improving the health of women in the first period of adulthood. 2023;8(1):29-38'}, {'type': 'BACKGROUND', 'citation': 'Hidayah N, Fatmawati R. The effectiveness of Gym Ball and ambon banana consumption against menstrual pain reduction in teenagers. 2022.'}, {'type': 'BACKGROUND', 'citation': 'Hemalatha R, Shanmugananth E, Murugaraj T, Velkumar VJJoCLM. Effects of Barre Exercise Versus Pilates Versus Aerobic Exercise on Pre-Menstrual Syndrome Among College Going Coastal Students. 2023;11:2440-51.'}, {'type': 'BACKGROUND', 'citation': 'Tianing NW, Nugraha MHS, Indrayani AW, Widyadharma IPEJBMJ. The difference in the effectiveness of warm compress and active stretching exercise in reducing dysmenorrhea pain. 2021;10(3):1041-4.'}, {'type': 'BACKGROUND', 'citation': 'Ali Z, Cardoza J. A Study on Effects of Aerobic Exercises on Quality of Life in Primary Dysmenorrhea in Bangalore. Natural Volatiles and Essential Oils. 2021;8:5304-12.'}]}, 'descriptionModule': {'briefSummary': 'Group A will be given Barre and gym ball exercises. Group B will be given Barre exercises. All these sessions will be of 30-minute 3session per week for 12 weeks.', 'detailedDescription': 'This will be a randomized controlled trial conducted on 42 participants. Data will be collected from USKT (University of Sialkot) and UMT (University of Management and Technology Sialkot by using non-probability convenience sampling technique. WaLLiD score scale is used to determine the severity of dysmenorrhoea. Girls between the age of 17 to 25 with history of dysmenorrhea will be included in this study. Participants who has history of secondary dysmenorrhea, Diagnosed with polycystic ovarian syndrome will be excluded from this study. A sample of 42 will be divided in to two groups with 21 participants in each group. Group A will be given Barre and gym ball exercises. Group B will be given Barre exercises. All these sessions will be of 30 minute 3session per week for 12 weeks. Pre and post assessment of pain, distress , severity of dysmenorrhoea and quality of life will be done by using numeric pain rating scale, menstrual distress questionnaire, WaLLiD scale and Q-LES-Q-SF questionnaire. Data will be analyzed by using SPSS version 26.0.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '17 Years', 'genderBased': True, 'genderDescription': 'diagnosed with primary dysmenorrhea', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female suffered from primary dysmenorrhea diagnosed through WaLLiD score range from 5-12\n* Female having 5 and above score on Numerical Pain Rating Scale\n* Female having regular menstrual period form at least 3 months\n* Female having a history of dysmenorrhea occurring at least three times in the past six months\n\nExclusion Criteria:\n\n* Females using hormonal contraception.\n* Females who are married.\n* Females with secondary dysmenorrhea\n* Females diagnosed with polycystic ovarian syndrome\n* Females having menstrual issues\n* Females who take analgesic\n* Females having BMI \\> 25\n* Participants who show unwillingness to participate in the study'}, 'identificationModule': {'nctId': 'NCT06750393', 'briefTitle': 'Combined Effects of Barre and Gym Ball Exercises in Primary Dysmenorhoea', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Combined Effects of Barre and Gym Ball Exercises on Pain, Distress and Quality of Life in Primary Dysmenorrhoea', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0528'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Barre exercise with gym ball exercise', 'description': 'The Barre exercises will be administered to the participant of Group A for a period of 3 month. Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week\n\n× 12. Gym ball exercises program include Knee tucks, leg curls, back extension exercises', 'interventionNames': ['Other: Barre exercise along with gym ball exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Barre exercises', 'description': 'The Barre exercises for a period of 3 month Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week\n\n× 12. During', 'interventionNames': ['Other: Barre exercises']}], 'interventions': [{'name': 'Barre exercise along with gym ball exercises', 'type': 'OTHER', 'description': 'The Barre exercises will be administer to the participant of Group A for a period of 3 month.\n\nEach exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week\n\n× 12. Gym ball exercises program include Knee tucks, leg curls, back extension exercises', 'armGroupLabels': ['Barre exercise with gym ball exercise']}, {'name': 'Barre exercises', 'type': 'OTHER', 'description': 'The Barre exercises for a period of 3 month Each exercise will be given for 10 s hold × 12 times/set × 3 sets/day × 3 days/week\n\n× 12. During', 'armGroupLabels': ['Barre exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '51310', 'city': 'Sialkot', 'state': 'Pjunjab', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'hina gul, MSOMPT', 'role': 'CONTACT', 'email': 'hina.gul@riphah.edu.pk', 'phone': '03214979172'}, {'name': 'Muqaddas aslam, MSPT(WH)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Sialkot, University of Management Technology', 'geoPoint': {'lat': 32.49268, 'lon': 74.53134}}], 'centralContacts': [{'name': 'imran gul, PhD', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'hina gul, MSOMPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}