Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 11:52 AM
Study NCT ID:
NCT06319651
Status:
COMPLETED
Last Update Posted:
2024-07-23
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial (RCT). Pre \\& Post data collection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Independence Measure', 'timeFrame': '6 Days', 'description': "The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.\n\nIs an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.\n\nUses the level of assistance an individual needs to grade functional status from total independence to total assistance).\n\nThe tool is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.\n\nFIM 3 levels."}, {'measure': '6 Minute Walk Test', 'timeFrame': '6 Days', 'description': 'The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity'}, {'measure': 'Forced expiratory volume (FEV1)', 'timeFrame': '6 Days', 'description': "Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry"}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': '6 Days', 'description': "Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry"}, {'measure': 'FEV1/FVC ratio', 'timeFrame': '6 Days', 'description': "The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85. It's measured by spirometry"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery bypass grafting', 'Cardiac rehabilitation', 'Resistance band exercise'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.', 'detailedDescription': 'This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Descriptive analysis will be applied. Data will be collected from Rehmatul lil Alameen Institute of cardiology Lahore. Sample size will be 56, 28 in each group. In addition to the routine Phase 1 cardiac rehabilitation for experimental group the exercise protocol consisted of 10 minutes of warm up, elastic band strength exercise protocol (30 minutes) and cool down (5 minutes) so that an exercise session lasted about 45-50 minutes, exercise will performed circularly 2 sets, 10 repetition with a 2 minute rest after each cycle and monitored the performance of exercise for 6 days. Resisted band exercise are Extending thighs, Closing thighs, Opening thighs, Bending thighs, Dorsiflexion, Plantarflexion. For control group routine Phase 1 cardiac rehabilitation only. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 35 to 60\n* Female and Male both\n* Hemodynamic stable patients\n* Arrhythmias or angina not present\n* Post elective sternotomy surgery\n* Post extubating\n\nExclusion Criteria:\n\n* Chronic obstructive pulmonary disease\n* Neurological Sequelae\n* Neuromuscular disease\n* Emergency or off pump surgery\n* Surgical re-intervention\n* Patient who remained on mechanical ventilation longer than 24 hours\n* Patient who had a baseline partial pressure of oxygen (PaO2) less than 75 mmHg and partial pressure of carbon dioxide (PCO2) 45 mmHg\n* Patients who had history of respiratory tract infection within a period of three months'}, 'identificationModule': {'nctId': 'NCT06319651', 'briefTitle': 'Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation on Functional Recovery Among Post Coronary Artery Bypass Grafting Patients', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/23/0360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'In addition to the routine Phase 1 cardiac rehabilitation, Resistance Exercises\n\n* Extending thighs\n* Closing thighs\n* Opening thighs\n* Bending thighs\n* Bending ankles\n* Ankle opening', 'interventionNames': ['Other: Lower Limb Resistance Band Exercises', 'Other: Routine Phase 1 cardiac rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine Phase 1 cardiac rehabilitation', 'description': 'Routine Phase 1 cardiac rehabilitation only.', 'interventionNames': ['Other: Routine Phase 1 cardiac rehabilitation']}], 'interventions': [{'name': 'Lower Limb Resistance Band Exercises', 'type': 'OTHER', 'description': '* Extending thighs\n* Closing thighs\n* Opening thighs\n* Bending thighs\n* Bending ankles\n* Ankle opening', 'armGroupLabels': ['Experimental Group']}, {'name': 'Routine Phase 1 cardiac rehabilitation', 'type': 'OTHER', 'description': 'Routine Phase 1 cardiac rehabilitation only.', 'armGroupLabels': ['Experimental Group', 'Routine Phase 1 cardiac rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Rehmatul lil Alameen Institute of cardiology', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad Faizan Hamid, Ms-CPPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}