protocolSection identificationModule nctId: NCT06283940, orgStudyIdInfo id: 281694, briefTitle: Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation, acronym: TAVI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-01, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Vastra Gotaland Region, class: OTHER_GOV, descriptionModule briefSummary: Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life., conditionsModule conditions: Aortic Valve Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intervention group and matched controls based on age, gender and exercise capacity in watt., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Data collection will be conducted by a physiotherapist not involved in the intervention., enrollmentInfo count: 135, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapist-led exercise based cardiac rehabilitation (PT-X), outcomesModule primaryOutcomes measure: Exercise capacity in watt, primaryOutcomes measure: Rating of perceived exertion Borg RPE scale 6-20, primaryOutcomes measure: Exercise capacity in Watt, primaryOutcomes measure: Rating of perceived exertion Borg RPE scale 6-20, primaryOutcomes measure: Muscular endurance test, shoulder flexion, primaryOutcomes measure: Muscular endurance test, shoulder flexion, primaryOutcomes measure: Muscle endurance test, shoulder abduction, primaryOutcomes measure: Muscle endurance test, shoulder abduction, primaryOutcomes measure: Muscle endurance test, unilateral heel-lift, primaryOutcomes measure: Muscle endurance test, unilateral heel-lift, primaryOutcomes measure: Lower extremity function, primaryOutcomes measure: Lower extremity function, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Physical activity, primaryOutcomes measure: Self-assessed level of physical activity, primaryOutcomes measure: Self-assessed level of physical activity, primaryOutcomes measure: Health Related Quality of Life, primaryOutcomes measure: Health Related Quality of Life, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Frailty, secondaryOutcomes measure: Hospital admission, secondaryOutcomes measure: Hospital admission, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False