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Clinical Trial Summary

Most children with congenital heart disease (CHD) are expected to survive until adulthood. In addition to physical limitations, the growing adolescents with CHD are also challenged at the psychosocial domains. Previous studies have investigated the frailty of elderly, but the research on the intervention to the frailty of adolescents with CHD has been limited. The aims of this study will apply the Walking Instruction based on Self-Efficacy (WISE) program to examine the long-term effects of improving frailty state and quality of life for adolescents with CHD.


Clinical Trial Description

This proposal will conduct a three-year series of studies. In the first year, a cross-sectional survey will be used to evaluate the applicability of the Fried frailty index to adolescents with CHD, and to examine the correlation between frailty index and quality of life in adolescent patients. In the second year, investigators will conduct individual in-depth interviews with selected pre-frailty/frailty adolescent participants and their main caregivers to gain insights into their views, connotations and support needs for frailty, which will serve as the basis for the design of the next interventional study. In the third year, the WISE program will be developed to provide 12-week walking self-efficacy improvement education strategies and exercise bracelets with heart rate monitoring. The recruited pre-frailty/frailty adolescent participants will be randomly assigned to experimental and control groups respectively in the pretest-posttest control group design. The changes in frailty state and quality of life for the two groups will be evaluated at 6, 12 and 24 weeks. The results of this study can provide frailty evaluation indicators for adolescents with CHD, timely detect the pre-frailty stage, and provide an important reference for the prevention of frailty intervention for adolescents with CHD as early as possible. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05533346
Study type Interventional
Source National Yang Ming University
Contact
Status Withdrawn
Phase N/A
Start date July 1, 2023
Completion date December 30, 2025

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