Ignite Creation Date:
2025-12-24 @ 11:55 AM
Ignite Modification Date:
2025-12-31 @ 7:33 PM
Study NCT ID:
NCT05706961
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-07', 'studyFirstSubmitDate': '2023-01-22', 'studyFirstSubmitQcDate': '2023-01-22', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Quality of Life questionnaire', 'timeFrame': '4th weeks', 'description': 'Changes from baseline to 4 week, The 14 items in the HeartQoL scale form a bi-dimensional questionnaire with a 10-item HeartQoL physical subscale and a 4-item HeartQoL emotional subscale that provides a global assessment and evaluation of how much a patient with angina, MI, or heart fail.'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Test (6MWT)', 'timeFrame': '4th week', 'description': 'Changes from baseline to 4 week, The 6MWT can be used in preschool children (2-5 years), children (6-12 years) adults (18-64 years), elderly adults (65+) with a wide range of diagnoses including. The test was initially designed to help in the assessment of patient with cardiopulmonary is'}, {'measure': 'BORG Rating of Perceived exertion', 'timeFrame': '4th Week', 'description': 'Changes from baseline to 4 week, The Borg RPE Scale is a 15-point scale (6 to 20) used to rate subjective experiences during physical exertion. This subjective load scale can help estimate load symptoms, such as the degree of exertion, the degree of load and fatigue. The Borg scale among'}, {'measure': 'Pulse rate', 'timeFrame': '4th Week', 'description': 'Changes from baseline to 4 week, Pulse rate will be measured through the Pulse Oximeter in beats per min before and after the exercise for the patient safety during exercise'}, {'measure': 'Liebowitz Social Anxiety Scale', 'timeFrame': '4th Week', 'description': 'Changes from baseline to 4 week, The LSAS is a 24-item scale that assesses fear of social situations and avoidance throughout the previous week. It includes 11 things that deal with social contact and 13 ones that deal with public performance. A physician rates each item on two 4-point L'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'To determine the effect of power walking on quality of life in Post CABG population undergoing phase 2 cardiac rehabilitation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female subject\n* Age will be from 50 to 70\n* Four weeks after CABG surgery patient are eligible to participate\n* Patient able to walk on Treadmill with Cardiac symptoms stable or absent\n* Appropriate HR response to exercise\n\nExclusion Criteria:\n\n* Those patients with contraindications to exercise or clinical risk factors, such as musculoskeletal, neurological, pulmonary or metabolic disorder were all excluded from the study.'}, 'identificationModule': {'nctId': 'NCT05706961', 'briefTitle': 'Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effect Of Power Walking On Quality Of Life In Post CABG Patient Undergoing Phase 2 Cardiac Rehabilitation', 'orgStudyIdInfo': {'id': 'REC/01374 Awais Ahmed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Power Walking', 'interventionNames': ['Other: Power Walking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized Outpatient Cardiac Rehabilitation', 'interventionNames': ['Other: Standardized Outpatient Cardiac Rehabilitation']}], 'interventions': [{'name': 'Power Walking', 'type': 'OTHER', 'description': 'For 1- 2 Week 60% of the target heart rate with 5,000 to 7,500 steps/day Total 30 min Session The exercise intensity was set at 60% of the target heart rate during the first 2 weeks.\n\nFor 3- 4 week 70 % of the target heart rate with 7,500 to 10,000 steps/day Total 30 min Session B) Progressive increase walk according to 6MWD as improved Low intensity', 'armGroupLabels': ['Power Walking']}, {'name': 'Standardized Outpatient Cardiac Rehabilitation', 'type': 'OTHER', 'description': 'For 1- 2 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 60 % of of target heart rate, resistive ex with 1- 3 kg of weight for 20 min and 10 min of cool down)\n\nFor 3 - 4 week Standardized Outpatient Cardiac Rehabilitation (includes warm up of 5 min, aerobic 70 % of target heart rate, resistive ex with 2- 3 kg of weight for 20 min and 10 min of cool down)', 'armGroupLabels': ['Standardized Outpatient Cardiac Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22010', 'city': 'Abbottābād', 'state': 'Khyber PkahtoonKhwa', 'country': 'Pakistan', 'facility': 'Women Institute of Rehabilitation Sciences (WIRS) and Jinnah International Hospital'}], 'overallOfficials': [{'name': 'Muhammad Iqbal Tariq, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}