Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-30 @ 3:24 AM
Study NCT ID:
NCT07076667
Status:
RECRUITING
Last Update Posted:
2025-07-22
First Post:
2025-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Benson's Relaxation and Tai Chi in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-03', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MODIFIED BORG DYSPNEA SCALE', 'timeFrame': '8 weeks', 'description': 'The MBS is a valid and reliable assessment tool for dyspnea. It is a tool to assess and rate the difficulty in breathing (dyspnea) rated from 0 to 10. 0 shows no dyspnea whereas 10 shows max dyspnea.'}, {'measure': 'SIX MINUTE WALK TEST', 'timeFrame': '8 weeks', 'description': 'The 6 MWT is safe,easy to administer,better tolerated, and reflects activities of daily living.When conducting the 6MWT do not walk with the patient and do not assist the patient in carrying or pulling his or her supplemental oxygen.The patient should walk alone,not with other patients.Do not use an oval or circular track. Use standardized phrases while speaking to the patient, because your encouragement and enthusiasm can make a difference of upto 30% in the 6MWD.Count the laps with a lap counter.'}, {'measure': 'SPIROMETER', 'timeFrame': '8 weeks', 'description': 'Spirometers arei nstruments to conduct spirometry tests.Earlier,spirometers were of either rolling model or bellows type but the recent ones are electronic and fully automated using digital turbine and flow sensors that require no calibration. Though spirometry does not measure the individual lung volumes,it measures the forced vital capacity (FVC).'}], 'secondaryOutcomes': [{'measure': "St.GEORGE'S RESPIRATORY QUESTIONNAIRE", 'timeFrame': '8 weeks', 'description': "The St George's Respiratory Questionnaire is a standardized self-completed questionnaire for measuring impaired health and perceived well-being ('quality of life') in airways disease. It has been designed to allow comparative measurements of health between patient populations and quantify changes in health following therapy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benson relaxation technique', 'Tai Chi', 'Pulmonary rehabilitation'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '24293462', 'type': 'BACKGROUND', 'citation': 'Cavailles A, Brinchault-Rabin G, Dixmier A, Goupil F, Gut-Gobert C, Marchand-Adam S, Meurice JC, Morel H, Person-Tacnet C, Leroyer C, Diot P. Comorbidities of COPD. Eur Respir Rev. 2013 Dec;22(130):454-75. doi: 10.1183/09059180.00008612.'}, {'type': 'BACKGROUND', 'citation': '2. LeungJM,ObeidatMe,SadatsafaviM,SinDD.Introductiontoprecisionmedicinein COPD. European Respiratory Journal. 2019;53(4).'}, {'type': 'BACKGROUND', 'citation': '3. AgustÃA,VogelmeierC,FanerR.COPD2020:changesandchallenges.American Physiological Society Bethesda, MD; 2020. p. L879-L83.'}, {'pmid': '37938356', 'type': 'BACKGROUND', 'citation': 'Nazari AM, Zare-Kaseb A, Arbabi Z, Gholampour MH, Emami Zeydi A, Ghazanfari MJ. The effect of Benson relaxation technique on cancer patients: a systematic review. Support Care Cancer. 2023 Nov 8;31(12):681. doi: 10.1007/s00520-023-08142-2.'}, {'type': 'BACKGROUND', 'citation': "JonesP,QuirkF,BaveystockC.TheStGeorge'sRespiratoryQuestionnaire.Respiratory medicine. 1991;85:25-31; discussion 3"}]}, 'descriptionModule': {'briefSummary': "Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disorder that significantly impacts respiratory function and quality of life. As COPD patients often experience symptoms such as dyspnea, fatigue, and anxiety, non-pharmacological interventions like Benson's Relaxation Technique and Tai Chi are gaining attention for their potential benefits in managing these symptoms.This study aimed to compare the effectiveness of Benson's Relaxation Technique and Tai Chi on improving dyspnea, physical endurance, and quality of life in COPD patients.", 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. An increasing number of studies show promising results for the performance of Tai Chi as an apppropriate addition in pulmonary rehabilitation. The Benson Relaxation Technique is a form of relaxation response therapy that can be beneficial for individuals with chronic obstructive pulmonary disease (COPD).This technique involves a series of steps designed to elicit the body's natural relaxation response, which can help manage stress and improve overall well-being. For COPD patients, incorporating breathing exercises can be especially beneficial. Slow,deep breathing can help improve oxygen intake and reduce the feeling of breathlessness. Controlled Breathing focus on taking slow, deep breaths in through the nose and out through the mouth. Pursed-lip breathing (breathing out through tightly pressed lips) can be particularly useful. It will be randomized clinical trial. Age of selected subjects will be between 40 to 60 years and data will be collected from Bahawalpur Victoria hospital. Sample size is 54. There will be 2 groups, group A will receive Benson'sr elaxation technique for 5 days per week for 45 minutes for 8 weeks and group B will receive TaiChi 5 days per week for 45 minutes for 8 weeks. Exercise will be performed to evaluate pulmonary functions and breathlessness. The Sampling Technique is non probability Convenience sampling technique. Study will be Conducted in Department of Pulmonary and Critical Care Medicine. After data collection, data will be analyzed by using SPSS version 25. It will be used aiming to determine the comparative effects of Benson's relaxation technique and Tai Chi in COPD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age40 to 50\n* Bothmaleandfemale\n* DiagnosedmoderatetosevereCOPDpatients\n* Participants must be physicallyable to participate in Tai Chi or Benson relaxation technique\n* Participantsmustbewillingtoparticipate\n\nExclusion Criteria:\n\n* Pulmonaryhypertension\n* Congenitalheartdisease(recentmyocardialinfarction,unstableangina,or uncontrolled hypertension)\n* Spinal deformities\n* Lossof consciousness'}, 'identificationModule': {'nctId': 'NCT07076667', 'briefTitle': "Effects of Benson's Relaxation and Tai Chi in COPD", 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': "Comparative Effects of Benson's Relaxation Technique and Tai Chi in COPD", 'orgStudyIdInfo': {'id': 'REC/RCR & AHS/24/0353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': "Benson'srelaxationtechnique", 'description': '"Benson\'s Relaxation Technique"along with the standard COPD care and medication.', 'interventionNames': ["Other: Benson's relaxation technique"]}, {'type': 'EXPERIMENTAL', 'label': 'TaiChi', 'description': '"Tai Chi relaxation Technique" along with the standard COPD care and medication', 'interventionNames': ['Other: Tai Chi']}], 'interventions': [{'name': "Benson's relaxation technique", 'type': 'OTHER', 'description': "effects of Benson's relaxation technique 5 days per week for 45 minutes for 8 weeks", 'armGroupLabels': ["Benson'srelaxationtechnique"]}, {'name': 'Tai Chi', 'type': 'OTHER', 'description': 'Tai Chi 5 days per week for 45 minutes for 8 weeks', 'armGroupLabels': ['TaiChi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Chak Eighty-seven -Twelve Left', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Iram Nawaz, Mphill', 'role': 'CONTACT', 'email': 'iram_029@yahoo.com', 'phone': '03324645227'}, {'name': 'Umra Khan, MS CPPT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bahawalpur Victoria Hospital', 'geoPoint': {'lat': 30.35931, 'lon': 72.60848}}], 'centralContacts': [{'name': 'imran amjad, Phd', 'role': 'CONTACT', 'email': 'imran.amjad@riphah.edu.pk', 'phone': '03324390125'}], 'overallOfficials': [{'name': 'Iram Nawaz, Mphill', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}