Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT03223558
Status:
COMPLETED
Last Update Posted:
2021-05-05
First Post:
2017-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Initiation of Post Sternotomy CArdiac Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D000082862', 'term': 'Aortic Valve 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'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'researchers will be blinded during baseline assessment prior to group allocation.\n\nParticipants and the clinical CR team will know the group allocation and therefore cannot be blinded. University hospitals for Coventry and Warwickshire NHS trust research and design department will generate the randomisation sequence remotely using permuted block randomisation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A single blinded parallel group randomised controlled trial will be used to determine non-inferiority of early (2 weeks post operation) vs usual care (6 weeks post operation ) CR for a period of 8 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-04', 'studyFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '12 months from surgery.', 'description': 'Number, type and severity of adverse events during trial'}], 'primaryOutcomes': [{'measure': 'Change in Six Minute Walk Test Distance', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'Distance walked unassisted in 6 minutes'}], 'secondaryOutcomes': [{'measure': 'Five Times Sit to Stand (Timed)', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'Time taken to stand up and sit down five times'}, {'measure': 'Handgrip Strength', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'Participant squeezes dynamometer as forcefully as possible. 3 times in each hand.'}, {'measure': 'Leg Strength', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'Isometric quadriceps extension. Measured using a dynamometer.'}, {'measure': 'Euroqol 5 Dimensions Questionnaire', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'Quality of life/cost benefit analysis questionnaire'}, {'measure': 'Short Form (SF) -12 Questionnaire', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': '12 Question Quality of Life Questionnaire'}, {'measure': 'Combined General Anxiety Disorder (GAD)-7 and Patient Health Questionnaire(PHQ) 9', 'timeFrame': 'Early Group- Change between baseline, 2 weeks post-surgery, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 6 weeks post-surgery and 14 weeks post-surgery and 12 months follow-up.', 'description': 'General Anxiety and Depression Questionnaire'}, {'measure': 'Client Service Receipt Inventory (CSRI) Questionnaire', 'timeFrame': 'Early Group- Change between baseline, 10 weeks post-surgery, and 12-month follow-up. Usual care group- Change between baseline, 14 weeks post-surgery and 12 months follow-up', 'description': 'health service use questionnaire for economic analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac rehabilitation'], 'conditions': ['Coronary Artery Disease', 'Aortic Valve Disease', 'Mitral Valve Disease']}, 'referencesModule': {'references': [{'pmid': '35731506', 'type': 'DERIVED', 'citation': 'Ennis S, Lobley G, Worrall S, Evans B, Kimani PK, Khan A, Powell R, Banerjee P, Barker T, McGregor G. Effectiveness and Safety of Early Initiation of Poststernotomy Cardiac Rehabilitation Exercise Training: The SCAR Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):817-824. doi: 10.1001/jamacardio.2022.1651.'}, {'pmid': '29574443', 'type': 'DERIVED', 'citation': 'Ennis S, Lobley G, Worrall S, Powell R, Kimani PK, Khan AJ, Banerjee P, Barker T, McGregor G. Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation. BMJ Open. 2018 Mar 23;8(3):e019748. doi: 10.1136/bmjopen-2017-019748.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to investigate the effects of starting exercise rehabilitation earlier than current practice after coronary artery bypass graft(CABG) or Aortic/Mitral valve replacement (VR) surgery.', 'detailedDescription': 'The trial will compare health improvements after cardiac rehabilitation, (CR) between participants randomly allocated to one of two groups: an early CR group starting exercise after 2 weeks, and a usual care group starting at 6 weeks. It will also collect information on the financial cost of earlier CR to both the health service and the patients.\n\nAll primary and secondary outcome measures will be taken at baseline (1 week) and repeated at the start and end of 8 weeks exercise rehabilitation program (2 and 10 weeks from baseline for the early group, 6 and 14 weeks in the usual care group respectively) and at 12 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation\n* Able to provide written informed consent\n* Male or female 18 years of age or greater\n\nExclusion Criteria:\n\n* Patients with any of the following:\n\n * Serious cardiac arrhythmias\n * Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise\n * Enrolled on another clinical trial that involved exercise\n * Unable to enroll for duration of study\n* Patients who are unable to provide written consent.\n* Patients under the age of 18 or over the age of 90.'}, 'identificationModule': {'nctId': 'NCT03223558', 'acronym': 'SCAR', 'briefTitle': 'Early Initiation of Post Sternotomy CArdiac Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Coventry and Warwickshire NHS Trust'}, 'officialTitle': 'Early Initiation of Cardiac Rehabilitation Exercise Training After Sternotomy: A Randomised Controlled Trial and Economic Evaluation', 'orgStudyIdInfo': {'id': 'SE191516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'early rehab group', 'description': 'start of 8 weeks cardiac rehabilitation 2 weeks following surgery', 'interventionNames': ['Behavioral: timing of initiation of cardiac rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care group', 'description': 'start 8 weeks of cardiac rehabilitation 6 weeks post surgery', 'interventionNames': ['Behavioral: timing of initiation of cardiac rehabilitation']}], 'interventions': [{'name': 'timing of initiation of cardiac rehabilitation', 'type': 'BEHAVIORAL', 'description': 'earlier timing of cardiac rehabilitation', 'armGroupLabels': ['early rehab group', 'usual care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Cv2 2DX', 'city': 'Coventry', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'UHCW NHS trust', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}], 'overallOfficials': [{'name': 'Stuart A Ennis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UHCW NHS trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Coventry and Warwickshire NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Coventry University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}