Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT04330560
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The masking will be imposed on the investigator who will be involved with the recruitment of the participant to prevent selection bias. The allocation of the participant to a group will be randomised using computer-generated random numbers by the other investigator who did not involve in recruiting the participant.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility (Recruitment procedure)', 'timeFrame': '12 weeks', 'description': "To inform the patient's acceptability towards recruitment procedure"}, {'measure': 'Feasibility (Randomization procedure)', 'timeFrame': '12 weeks', 'description': "To inform the patient's acceptability towards randomization procedure"}, {'measure': 'Feasibility (Cardiac rehabilitation program adherence)', 'timeFrame': '12 weeks', 'description': "To inform the patient's acceptability towards cardiac rehabilitation program adherence"}, {'measure': 'Feasibility (Assessment adherence)', 'timeFrame': '12 weeks', 'description': "To inform the patient's acceptability towards assessment adherence"}, {'measure': 'Feasibility (Safety - hospital readmission)', 'timeFrame': '12 weeks', 'description': "To inform the patient's safety on hospital readmission"}, {'measure': 'Feasibility (Safety - cardiac adverse events)', 'timeFrame': '12 weeks', 'description': "To inform the patient's safety on cardiac adverse events"}, {'measure': 'Exercise capacity during exercise stress test', 'timeFrame': '12 weeks', 'description': 'Changes of metabolic equivalents (METs)'}, {'measure': 'Exercise capacity during six-minutes walking test', 'timeFrame': '12 weeks', 'description': 'Changes of walking distance (meter)'}], 'secondaryOutcomes': [{'measure': 'Exercise adherence - Steps count', 'timeFrame': '12 weeks', 'description': "Changes in patient's weekly steps count."}, {'measure': 'Exercise adherence - Exercise frequency', 'timeFrame': '12 weeks', 'description': "Changes in patient's weekly exercise frequency."}, {'measure': 'Exercise adherence - Exercise duration', 'timeFrame': '12 weeks', 'description': "Changes in patient's weekly exercise duration (minutes)."}, {'measure': 'Hospital readmission', 'timeFrame': '12 weeks', 'description': 'Changes of frequency of hospital readmission throughout the intervention'}, {'measure': 'Cardiac adverse events', 'timeFrame': '12 weeks', 'description': 'Changes of frequency of cardiac adverse events throughout the intervention'}, {'measure': 'Blood collection - serum cholesterol', 'timeFrame': '12 weeks', 'description': 'Changes of serum cholesterol (mmol/L)'}, {'measure': 'Blood collection - triglyceride', 'timeFrame': '12 weeks', 'description': 'Changes of serum triglyceride (mmol/L)'}, {'measure': 'Blood collection - high-density lipoproteins (HDL)', 'timeFrame': '12 weeks', 'description': 'Changes of high-density lipoproteins (HDL) (mmol/L)'}, {'measure': 'Blood collection - low-density lipoprotein (LDL)', 'timeFrame': '12 weeks', 'description': 'Changes of low-density lipoprotein (LDL) (mmol/L)'}, {'measure': 'Blood collection - Haemoglobin A1C (HA1c)', 'timeFrame': '12 weeks', 'description': 'Changes of Haemoglobin A1C (HA1c) (mmols/mol)'}, {'measure': 'Body mass (kg)', 'timeFrame': '12 weeks', 'description': 'Changes of body mass (kg)'}, {'measure': 'Body mass index (BMI) (kg/m2)', 'timeFrame': '12 weeks', 'description': 'Changes of BMI (kg/m2)'}, {'measure': 'Usability scale score', 'timeFrame': '12 weeks', 'description': 'Measured by using mHealth App Usability Questionnaire (MAUQ). Indicators are evaluated according to the seven-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on smartphone app ease of use, interface and satisfaction, and usefulness.'}, {'measure': 'Factors associated with non-adherence to cardiac rehabilitation program score', 'timeFrame': '12 weeks', 'description': 'Measured by using Cardiac Rehabilitation Barriers Scale (CRBS) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree."'}, {'measure': 'Quality of life (QOL) score', 'timeFrame': '12 weeks', 'description': 'Measured by using WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on the physical health, psychological, social relationship and environment.'}, {'measure': 'Fitness tracker acceptance score', 'timeFrame': '12 weeks', 'description': 'Measured by using Technology Acceptance Model (TAM) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on the effort expectancy, performance expectancy, facilitating conditions, perceived enjoyment, perceived fee, perceived privacy, perceived trust, perceived value, social influence, perceived health increase and intention to use.'}, {'measure': "Participant's acceptance to the exercise-based telemonitoring", 'timeFrame': '12 weeks', 'description': "Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'referencesModule': {'references': [{'pmid': '34741536', 'type': 'DERIVED', 'citation': 'Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The intervention will involve a system that comprises a wrist-worn activity tracker and a smartphone app that acts as a medium to link to the healthcare website', 'detailedDescription': 'Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT.\n\nRandomized control trial objective: -\n\n1. Primary Objective: To determine the exercise capacity among patients with CHD,\n2. Secondary Objectives: To assess patient exercise adherence and determine the changes in other clinical health outcomes.\n\nStudy Population: Patients with coronary heart disease\n\nDescription of Sites/Facilities Enrolling Participants: Patient engagement with the cardiac rehabilitation phase 2 (CRP2) at the University Malaya Medical Centre (UMMC).\n\nDescription of Study Intervention: This study is a mixed-methods study consisting of a quantitative study (feasibility, preliminary evaluation, and full randomized control trial) and a qualitative study (interviewing). The present study will be conducting a single-blinded, three-arm, parallel over a 12-weeks study period during CRP2. Measurement will be collected during pre-and post-test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with 18 years old and above with indexed diagnosis of coronary heart disease (CHD) and are referred for Cardiac Rehabilitation Program;\n* Low- and moderate-risk patient category (controlled BP, sinus rhythm at 60-90 bpm, pain score\\< 3/10) and received a statement of medical clearance by a CR physician to undertake exercise with minimal supervision;\n* The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and\n* Participant must be able to able to read, speak and understand English and Malay.\n\nExclusion Criteria:\n\n* Heart failure NYHA Stage 3-4, pulse undetected by trackers;\n* The participant who cannot detect their pulse through wrist-worn tracker;\n* Do not own a smartphone with the mobile internet/Wi-Fi ; and\n* Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise.'}, 'identificationModule': {'nctId': 'NCT04330560', 'briefTitle': 'Exercise-based Telerehabilitation in the Cardiac Rehabilitation Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Feasibility and Preliminary Evaluation and the Effects of Exercise-based Telerehabilitation on the Acceptability and Safety, and Clinical Effectiveness Among Patients With Coronary Heart Disease Undergoing the Cardiac Rehabilitation Program', 'orgStudyIdInfo': {'id': '2018112-6846'}, 'secondaryIdInfos': [{'id': 'RF009C-2018', 'type': 'OTHER_GRANT', 'domain': 'University of Malaya Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ex group', 'description': 'Receive CR telerehabilitation (exercise telemonitoring link to the healthcare platform + teleconsultation)', 'interventionNames': ['Device: Exercise telemonitoring connects to healthcare platform', 'Device: Exercise teleconsultation', 'Procedure: Other CR components']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Com group', 'description': 'Receive CR telerehabilitation (exercise self-monitoring + teleconsultation)', 'interventionNames': ['Device: Exercise self-monitoring', 'Device: Exercise teleconsultation', 'Procedure: Other CR components']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C group', 'description': 'Standard care - traditional center-based CR', 'interventionNames': ['Procedure: Standard care']}], 'interventions': [{'name': 'Exercise telemonitoring connects to healthcare platform', 'type': 'DEVICE', 'description': 'The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) link to the healthcare practitioner', 'armGroupLabels': ['Ex group']}, {'name': 'Exercise self-monitoring', 'type': 'DEVICE', 'description': 'The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) for exercise self-monitoring.', 'armGroupLabels': ['Com group']}, {'name': 'Exercise teleconsultation', 'type': 'DEVICE', 'description': 'Conducted through smartphone video call app.', 'armGroupLabels': ['Com group', 'Ex group']}, {'name': 'Other CR components', 'type': 'PROCEDURE', 'description': 'Including dietary, psychology, education conducted at the center.', 'armGroupLabels': ['Com group', 'Ex group']}, {'name': 'Standard care', 'type': 'PROCEDURE', 'description': 'Undergoing standard care by cardiac rehabilitation at the center', 'armGroupLabels': ['C group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Rehabilitation Medicine, Pusat Perubatan Universiti Malaya', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Anwar Suhaimi, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}, {'name': 'Wan Ling Lee, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}, {'name': 'Sanjay Rampal Lekhraj Rampal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}