Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation - Trial NCT06283940

Timeline & Enrollment

Primary Outcome

Exercise capacity in watt,Rating of perceived exertion Borg RPE scale 6-20,Exercise capacity in Watt,Rating of perceived exertion Borg RPE scale 6-20,Muscular endurance test, shoulder flexion,Muscular endurance test, shoulder flexion,Muscle endurance test, shoulder abduction,Muscle endurance test, shoulder abduction,Muscle endurance test, unilateral heel-lift,Muscle endurance test, unilateral heel-lift,Lower extremity function,Lower extremity function,Physical activity,Physical activity,Self-assessed level of physical activity,Self-assessed level of physical activity,Health Related Quality of Life,Health Related Quality of Life

Summary

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.

ICD-10 Classifications