Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 1:41 PM
Study NCT ID:
NCT05158569
Status:
COMPLETED
Last Update Posted:
2022-09-16
First Post:
2021-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Breathing Exercise for Hypertensive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007040', 'term': 'Hypoventilation'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2021-12-13', 'lastUpdatePostDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '4 weeks', 'description': 'Blood pressure is measured in millimeters of mercury (mm Hg). A blood pressure measurement has two numbers: The top number (systolic) is the pressure of the blood flow when your heart muscle contracts, pumping blood. The bottom number (diastolic) is the pressure measured between heartbeats. The patients are classified according to the range as follows. Hypertension stage 1 SYSTOLIC (mm of Hg): 121-139 DIASTOLIC (mm of Hg): 81-89'}], 'secondaryOutcomes': [{'measure': 'Health related Quality of life', 'timeFrame': '4 weeks', 'description': 'Measured through EuroQOL-five-dimensional-three-level (EQ-5D-3L) questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stage 1 hypertension', 'Diaphragmatic breathing', 'Slow breathing', 'Quality of life'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '25804100', 'type': 'BACKGROUND', 'citation': 'Jones CU, Sangthong B, Pachirat O, Jones DA. Slow breathing training reduces resting blood pressure and the pressure responses to exercise. Physiol Res. 2015;64(5):673-82. doi: 10.33549/physiolres.932950. Epub 2015 Mar 24.'}, {'type': 'BACKGROUND', 'citation': 'Janet SK, Mangala Gowri P. Effectiveness of deep breathing exercise on blood pressure among patients with hypertension. Int J Pharma Bio Sci 2017; 8(1):B256-60.'}, {'pmid': '28626434', 'type': 'BACKGROUND', 'citation': 'Ma X, Yue ZQ, Gong ZQ, Zhang H, Duan NY, Shi YT, Wei GX, Li YF. The Effect of Diaphragmatic Breathing on Attention, Negative Affect and Stress in Healthy Adults. Front Psychol. 2017 Jun 6;8:874. doi: 10.3389/fpsyg.2017.00874. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'To determine the Effectiveness of diaphragmatic breathing vs. slow breathing techniques on blood pressure and Quality of life in adults with stage 1 hypertension. In accessible literature limited data was found on the comparison of different breathing techniques. The current study will compare the effect of slow vs. diaphragmatic breathing exercises and will demonstrate which one is more effective.', 'detailedDescription': 'Literature reports that inspiratory muscle training is more effective in reducing Blood Pressure and voluntary diaphragmatic breathing at 10 or 6 breaths per minute for 10 min twice a day for 4 weeks is effective in producing positive outcomes in hypertensive patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient having stage 1 hypertension, Diagnosed after 1 week BP charting\n\nExclusion Criteria:\n\n* Patients taking antihypertensive medication Patient having comorbidities Smokers and women taking oral contraceptives'}, 'identificationModule': {'nctId': 'NCT05158569', 'briefTitle': 'Comparison of Breathing Exercise for Hypertensive Patients', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effectiveness of Diaphragmatic Breathing vs. Slow Breathing Techniques on Blood Pressure and Health-related Quality of Life in Adults With Stage 1 Hypertension', 'orgStudyIdInfo': {'id': 'Rec/01091 Kamran khan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow breathing exercise group', 'description': 'Slow breathing 5-6 breaths/minute, 3 sets of 5 minutes 2 times/day for 4 weeks.', 'interventionNames': ['Other: Slow breathing exercise group']}, {'type': 'EXPERIMENTAL', 'label': 'Diaphragmatic breathing exercise group', 'description': 'Diaphragmatic breathing, 3 sets of 5 minutes 2 times/day for 4 weeks.', 'interventionNames': ['Other: Diaphragmatic breathing exercise group']}], 'interventions': [{'name': 'Slow breathing exercise group', 'type': 'OTHER', 'description': 'The patient will be first asked to close one nostril with a thumb and slowly breathe in completely through the other for 6 seconds. This nostril will be then closed and the patient will exhale through the other nostril over a period of 6 seconds. These steps complete one breathing cycle. An attempt will be made to keep the breathing rate is about 5-6 breaths per minute. Such alternate nostril breathing cycles will be repeated continuously for a period of about 15 minutes (3 sets of 5 minutes) in one sitting.', 'armGroupLabels': ['Slow breathing exercise group']}, {'name': 'Diaphragmatic breathing exercise group', 'type': 'OTHER', 'description': 'Patients would be instructed to Sit or lie down in a comfortable place and put their hands on their belly.\n\nRelax the muscles in their neck and shoulders. Breathe in slowly through the nose, keeping their mouth closed. Feel the lungs fill with air and inflate like a balloon while their belly moves outward. Such breathing cycles will be repeated continuously for a period of about 15 (3 sets of 5 minutes) minutes in one sitting.', 'armGroupLabels': ['Diaphragmatic breathing exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19200', 'city': 'Swāt', 'state': 'KPK', 'country': 'Pakistan', 'facility': 'Zakir khan shaheed hospital matta'}], 'overallOfficials': [{'name': 'Mehwish Waseem, MSPT(CPPT)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}