protocolSection identificationModule nctId: NCT06370611, orgStudyIdInfo id: 2314027, briefTitle: Early Remote Rehabilitation to Improve Health of the Elderly After Cardiac Surgery. (RECARD Trial), acronym: RECARD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Ivy susanne Modrau, MD, class: OTHER, collaborators name: Aalborg University Hospital, descriptionModule briefSummary: An increasing number of older patients undergo heart surgery. Despite seemingly successful outcomes, these vulnerable patients may face prolonged decreased functional capacity, reduced self-efficacy, and impaired quality of life after discharge. Early engagement in physical activity and education plays a key role in health and well-being after heart surgery The goal of this clinical trial is to evaluate the effectiveness of an app-based exercise program and weekly calls from a physiotherapist in the early stages after open heart surgery.Eligible patients will be randomly assigned to either a control group receiving standard care or an intervention group, which will be introduced to an individually tailored exercise program as an addition to standard care.Follow-up is planned with an out-patient visit six weeks after discharge and a telephone interview six months post-surgery.All participants will undergo assessments at enrollment and during follow-up. Physical performance will be evaluated through physical tests. General well-being, quality of life, self-reported physical activity, and cost-effectiveness of the intervention will be assessed through questionnaires. Muscle health will be examined through blood sampling, CT scans, and muscle biopsies.The primary endpoint is the 30-second Chair Stand Test serving as a measurement of physical function., conditionsModule conditions: Cardiac Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Bi-center, prospective, randomized, controlled, parallel (1:1), two-arm, open-label, blinded evaluation (PROBE) trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Allocation cannot be concealed from the participants, care providers or investigator. Outcome assessors will be blinded regarding allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Early mobile health intervention supplemented by weekly calls from a physiotherapist, outcomesModule primaryOutcomes measure: Change (Δ) 30-second chair stand test (30CST) baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in 10-meter Walk Test (10MWT) baseline vs. 6-week FU, secondaryOutcomes measure: Difference in 6-minute Walk Test (6MWT) between groups at 6-week FU, secondaryOutcomes measure: Change (Δ) in WHO-5-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in ASS-2-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in MDI-2-score baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in Self-reported Physical Activity baseline vs. 6-week FU, secondaryOutcomes measure: Change (Δ) in EuroQol-score baseline vs. 6-week FU, secondaryOutcomes measure: Change in skeletal muscle mass maximum 3 months prior to surgery vs. 6-week FU, secondaryOutcomes measure: Cost-effectiveness analysis, secondaryOutcomes measure: Changes in markers of musculoskeletal health through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of inflammation through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of nutrition through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of liver function through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of kidney function through blood samples baseline vs. 6-week FU, secondaryOutcomes measure: Changes in markers of hormone levels through blood samples baseline vs. 6-week FU, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarlborg University Hospital, city: Aalborg, zip: 9000, country: Denmark, contacts name: Stian Ingemann-Molden, PT, MHSc, role: CONTACT, phone: +45 97664210, email: s.ingemannmolden@rn.dk, geoPoint lat: 57.048, lon: 9.9187, locations facility: Aarhus University Hospital, city: Aarhus, zip: 8200, country: Denmark, contacts name: Rikke Daugaard, PT, MHSc, role: CONTACT, phone: +45 41282266, email: daugaard@clin.au.dk, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False