Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT07232693
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telerehabilitation vs. Center-Based Rehab for Psychological Well-being After CABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in Peak Oxygen Consumption (VO₂ peak)', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in VO₂ peak, a measure of cardiopulmonary fitness, assessed via an exercise test. Unit: mL/kg/min.'}, {'measure': 'Change in 6-Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in the distance a patient can walk in six minutes, measuring functional exercise capacity. Unit: Meters.'}, {'measure': 'Change in Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in LVEF, assessed by echocardiography. Unit: Percentage (%).'}, {'measure': 'Adherence Rate', 'timeFrame': 'Through study completion, 12 weeks', 'description': 'The percentage of completed cardiac rehabilitation sessions out of the total prescribed sessions for the HBTCR and CBCR groups.'}], 'primaryOutcomes': [{'measure': 'Change in Anxiety Symptoms', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in the Hamilton Anxiety Scale (HAMA) score. The HAMA scale is a clinician-rated scale where higher scores indicate greater symptom severity.'}, {'measure': 'Change in Depression Symptoms', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in the 17-item Hamilton Depression Scale (HAMD) score. The HAMD is a clinician-rated scale where higher scores indicate greater symptom severity.'}], 'secondaryOutcomes': [{'measure': 'Change in Health-Related Quality of Life', 'timeFrame': 'Baseline, 12 Weeks', 'description': 'The change from baseline in scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The SF-36 assesses eight domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Scores for each domain range from 0 to 100, with higher scores indicating better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Bypass Grafting', 'Telerehabilitation', 'Anxiety', 'Depression', 'Quality of Life', 'Cardiac Rehabilitation'], 'conditions': ['Psychological Distress After Coronary Artery Bypass Grafting (CABG)']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to determine if a 12-week home-based telerehabilitation (HBTCR) program is as effective as traditional center-based cardiac rehabilitation (CBCR) in improving psychological well-being (anxiety and depression) and quality of life in patients who have undergone coronary artery bypass grafting (CABG). A third group receiving usual care served as a control.', 'detailedDescription': 'Psychological distress, such as anxiety and depression, is common after coronary artery bypass grafting (CABG) and negatively affects recovery and quality of life. While center-based cardiac rehabilitation (CBCR) effectively addresses these issues, participation is often limited by barriers like travel, cost, and scheduling. Home-based telerehabilitation (HBTCR) offers a potential solution. This single-center, prospective, three-arm randomized controlled trial was designed to compare the effectiveness of HBTCR versus CBCR and usual care. A total of 110 clinically stable patients, 4-8 weeks post-CABG, were randomly assigned in a 1:1:1 ratio to an HBTCR group, a CBCR group, or a control group. The intervention period was 12 weeks. The study hypothesized that the HBTCR program, which includes a personalized exercise plan, remote monitoring via a wearable device and mobile app, and weekly psychosocial support from a nurse, would be as effective as the traditional supervised in-person CBCR program in reducing symptoms of anxiety and depression and improving health-related quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 30-75 years.\n* 4-8 weeks post-Coronary Artery Bypass Grafting (CABG).\n* In clinically stable condition.\n* Had access to a smartphone and were willing to use it for the program.\n* Willing to participate in a 12-week rehabilitation program.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Presence of severe and unstable comorbidities (e.g., uncontrolled heart failure, recent stroke).\n* Severe orthopedic limitations that would prevent participation in exercise.\n* Significant cognitive impairment or psychiatric disorders that would interfere with participation.\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07232693', 'briefTitle': 'Telerehabilitation vs. Center-Based Rehab for Psychological Well-being After CABG', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Hebei Medical University'}, 'officialTitle': 'The Impact of Home-Based Telerehabilitation Versus Center-Based Cardiac Rehabilitation on Anxiety, Depression, and Quality of Life After Coronary Artery Bypass Grafting: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'S00775-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-Based Telerehabilitation (HBTCR) Group', 'description': 'Participants received a personalized 12-week exercise program to perform at home. They were provided with a wearable heart rate monitor and a mobile application to log their activities. A dedicated cardiac rehabilitation nurse contacted each patient weekly via phone or video call to review progress, adjust the exercise plan, and provide structured psychosocial support and counseling.', 'interventionNames': ['Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Center-Based Cardiac Rehabilitation (CBCR) Group', 'description': "Participants attended 36 supervised sessions at the hospital's cardiac rehabilitation center over 12 weeks (3 sessions/week). Each session included aerobic and resistance exercises. In addition, patients attended weekly group sessions for health education and psychosocial support, covering topics like stress management and coping strategies.", 'interventionNames': ['Behavioral: Home-Based Telerehabilitation Cardiac Rehabilitation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Participants received usual care, which included standard postoperative medical advice and health education pamphlets detailing general recommendations for diet, medication, and physical activity. They did not receive any structured exercise prescription or formal psychological support from the study team.', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Home-Based Telerehabilitation Cardiac Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.', 'armGroupLabels': ['Home-Based Telerehabilitation (HBTCR) Group']}, {'name': 'Home-Based Telerehabilitation Cardiac Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'A 12-week structured and remotely monitored cardiac rehabilitation program including a personalized exercise prescription (aerobic and resistance training), remote monitoring with a wearable heart rate sensor and mobile app, and weekly one-on-one psychosocial support and counseling via phone or video call from a rehabilitation nurse.', 'armGroupLabels': ['Center-Based Cardiac Rehabilitation (CBCR) Group']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Standard postoperative care including prescribed medications and routine follow-up, supplemented with health education pamphlets on lifestyle modification. No structured or supervised rehabilitation was provided.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Hebei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yan Liu', 'investigatorAffiliation': 'The First Hospital of Hebei Medical University'}}}}