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RECRUITING
NCT06283940
NA

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

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.

Official title: Effect of Physiotherapist-led Exercise-based Cardiac Rehabilitation in Older Patients With Aortic Stenosis Who Have Undergone TAVI?

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

135

Start Date

2024-07-29

Completion Date

2026-01

Last Updated

2024-08-13

Healthy Volunteers

No

Interventions

OTHER

Physiotherapist-led exercise based cardiac rehabilitation (PT-X)

Individually prescribed centralcirculatory aerobic exercise and muscular endurance training twice a week for 60 minutes each session over 12 weeks in a hospital-based setting, and two sessions of home-based exercise recorded in an exercise diary.

Locations (1)

SV Hospital group Alingsås hospital

Alingsås, Sweden