NCT05533346

Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With CHD

Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Yang Ming Chiao Tung University · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Frailty

Interventions

Type	Name	Description
BEHAVIORAL	with WISE (Walking Instruction based on Self-Efficacy)	Will be provided with walking health education leaflets and exercise measurement wristbands for exercise monitoring. Only the experimental group will be additionally given the interventional treatment of the WISE program: walk three times a week for at least 30 minutes each time, with a pace between 100-130 steps/min, and then increase the number or time weekly according to your personal ability, and remind you if the monitoring heart rate is higher than 170 times/min or the blood oxygen concentration is lower than 95%, and if the body feels any discomfort, it is necessary to stop taking a rest, and an educational strategy for improving self-efficacy of walking for 12 weeks is also provided.
BEHAVIORAL	without WISE (Walking Instruction based on Self-Efficacy)	The procedure of the control group was the same as that of the experimental group, both of which will be provided with walking health education leaflets and exercise measurement wristbands for exercise monitoring.

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-12-30
• Completion: 2025-12-30
• First posted: 2022-09-09
• Last updated: 2024-03-22

Locations

1 site across 1 country: Taiwan