protocolSection identificationModule nctId: NCT06323317, orgStudyIdInfo id: UW 21-405, briefTitle: A Prehabilitation Program for Frail Patients Undergoing Cardiac Surgeries/Procedures, acronym: PREHAB, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, descriptionModule briefSummary: The purpose of this study is to develop and evaluate a frailty-specific prehabilitation program for patients awaiting cardiac surgeries/procedures. The program aims to improve functional capacity, frailty level, cardiac-related physical functioning, health-related quality of life (HRQoL), psychological distress, major adverse cardiovascular and cerebral events (MACCE), hospital length of stay, and readmission rates.Cardiovascular disease is a leading cause of disability and morbidity globally, particularly in older adults. Frailty, a geriatric syndrome commonly seen in cardiac patients, complicates their perioperative care and leads to worse outcomes.Prehabilitation, which optimizes patients' physiological and functional capacities before surgery, has shown promise in general cardiac patients but requires a more comprehensive approach for frail individuals. This randomized controlled trial will recruit 50 Chinese adults awaiting elective cardiac surgeries/procedures in Hong Kong. Participants will be randomly assigned to either the intervention group, receiving a comprehensive prehabilitation program, or the control group, receiving routine preoperative care. Assessments will be conducted at baseline and at three postoperative time points.The findings will contribute to our understanding of the impact of frailty on postoperative outcomes and help develop strategies to improve patient care. Ultimately, this study aims to reduce healthcare burdens associated with cardiac disease-related morbidity and disability., conditionsModule conditions: Coronary Artery Bypass Grafting, conditions: Heart Valve Replacement, conditions: Transcatheter Aortic Valve Implantation, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The post-intervention data collector (research assistant) will be blinded to the group allocation to avoid performance and detection biases., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Multi-component exercise programme, interventions name: Attention Placebo, interventions name: Structured preoperative education, interventions name: Nutritional optimization, interventions name: Stress management, outcomesModule primaryOutcomes measure: The Short Physical Performance Battery (SPPB), primaryOutcomes measure: Weakness/ Grip Strength (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Slowness (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Low Physical Activity (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Self-reported Exhaustion (Fried Phenotype Frailty Assessment), primaryOutcomes measure: Unintentional Weight Loss (Fried Phenotype Frailty Assessment), primaryOutcomes measure: The Seattle Angina Questionnaire (SAQ), primaryOutcomes measure: The MacNew Heart Disease Health-Related Quality of Life Questionnaire, secondaryOutcomes measure: The Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Biomarkers-Serum albumin, secondaryOutcomes measure: Biomarkers- C-reactive protein, secondaryOutcomes measure: Major adverse cardiac and cerebrovascular events (MACCE), secondaryOutcomes measure: Hospital Length of stay, secondaryOutcomes measure: Hospital Readmissions, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Polly Wai Chi, status: RECRUITING, city: Hong Kong, state: Please Select, zip: 00000, country: Hong Kong, contacts name: Polly Wai Chi Li, PhD, role: CONTACT, email: pwcli@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False