Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01285193
Status:
UNKNOWN
Last Update Posted:
2011-01-27
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treating Hypertension With Breath Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], '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': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-26', 'studyFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastolic blood pressure', 'timeFrame': '2 months', 'description': 'Change in diastolic blood pressure from baseline to end value at 2 months.'}], 'secondaryOutcomes': [{'measure': 'Systolic blood presure', 'timeFrame': '2 months', 'description': 'Change in systolic blood pressure from baseline to end value at 2 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypertension', 'high blood pressure', 'treatment', 'breath control', 'breathing exercise', 'audio CD'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '11319675', 'type': 'RESULT', 'citation': 'Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. doi: 10.1038/sj.jhh.1001147.'}, {'pmid': '30121686', 'type': 'DERIVED', 'citation': 'Kow FP, Adlina B, Sivasangari S, Punithavathi N, Ng KK, Ang AH, Ong LM. The impact of music guided deep breathing exercise on blood pressure control - A participant blinded randomised controlled study. Med J Malaysia. 2018 Aug;73(4):233-238.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if blood pressure can be reduced in hypertensive subjects by regularising and slowing their breathing. This may be a safe and affordable complementary treatment for hypertension.', 'detailedDescription': 'This is a randomised controlled trial in which hypertensive subjects allocated to receive either a CD with relaxation music or one with the same music plus certain sound cues to guide the listener on when to breathe. The subjects will continue with their normal medications and the intervention will last 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years old\n* Patients with essential hypertension\n* Systolic BP from 140 to 159 mm Hg\n* Diastolic BP from 90 to 99 mm Hg\n* On hypertensive medication for at least 3 months before the study\n* Hypertensive medication unchanged during the 3 months before the study\n* Patients able to fill in a log sheet\n\nExclusion Criteria:\n\n* ischaemic heart disease\n* congestive heart failure\n* cardiac arrhythmias\n* renal failure\n* diabetes mellitus\n* previous stroke\n* major organ failure\n* cigarette smoking\n* respiratory diseases\n* psychiatric disorders\n* severe obesity (BMI \\>35 kg/m2)\n* hearing impairment\n* unable to operate a CD player or do not have access to a CD player\n* arm circumference \\<22 cm. or \\>42 cm.'}, 'identificationModule': {'nctId': 'NCT01285193', 'briefTitle': 'Treating Hypertension With Breath Control', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Penang Hospital, Malaysia'}, 'officialTitle': 'A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing', 'orgStudyIdInfo': {'id': 'CT10-HPP-001'}, 'secondaryIdInfos': [{'id': 'NMRR-10-686-6238', 'type': 'OTHER', 'domain': 'Ministry of Health Malaysia'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breath control', 'description': 'A music CD with sound cues is used to guide the subject to breathe in a regular and slower rate. This is practiced for at least 15 minutes a day over 2 months.', 'interventionNames': ['Behavioral: Breath control']}], 'interventions': [{'name': 'Breath control', 'type': 'BEHAVIORAL', 'otherNames': ['breathing exercise', 'slow breathing'], 'description': 'A music CD with sound cues is used to guide the subject to breathe in a regular and slower rate. This is practiced for at least 15 minutes a day over 2 months.', 'armGroupLabels': ['Breath control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10990', 'city': 'George Town', 'state': 'Pulau Pinang', 'country': 'Malaysia', 'contacts': [{'name': 'Kum Keong Ng, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ng Kum Keong', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}], 'centralContacts': [{'name': 'Kum Keong Ng, MBBS', 'role': 'CONTACT', 'email': 'ngkk@crc.gov.my', 'phone': '6042225761'}], 'overallOfficials': [{'name': 'Kum Keong Ng, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Centre, Penang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penang Hospital, Malaysia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, Malaysia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Ng Kum Keong', 'oldOrganization': 'Clinical Research Centre, Penang Hospital'}}}}