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

National Yang Ming Chiao Tung University

Status: Withdrawn

Conditions: Frailty

Treatments: Behavioral: without WISE (Walking Instruction based on Self-Efficacy); Behavioral: with WISE (Walking Instruction based on Self-Efficacy)

Study type: Interventional

Funder types: Other

Identifiers

NCT05533346

202112099RINA-202200361B0

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 12-18 years old.
2. Congenital heart disease diagnosed by a doctor before the age of 2.
3. The American New York Heart Association (NYHA) classifies the cardiac function as I-III grades.
4. Adolescents and their parents or guardians can communicate in Mandarin and Taiwanese and have normal cognitive abilities.
5. Those who are willing to cooperate with the research and complete the consent form.

Exclusion criteria

1. Received a heart transplant within one year.
2. Have undergone open-heart surgery within six months.
3. The New York Heart Association (NYHA) classifies the cardiac function as class IV.
4. Combined with other congenital diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Experimental - with WISE

Experimental group

Description:

The experimental group will provide walking health education leaflets and exercise measurement wristbands for exercise monitoring, and will be given the intervention of the WISE program: three times a week, each time walking for at least 30 minutes, with a pace between 100-130 steps/ minutes, and then increase the number or time weekly according to personal ability.

Treatment:

Behavioral: with WISE (Walking Instruction based on Self-Efficacy)

Control - without WISE

Active Comparator group

Description:

The procedure of the control group will be the same as that of the experimental group, providing walking and health education leaflets and exercise measurement wristbands for exercise monitoring, but no intervention in the WISE program.

Treatment:

Behavioral: without WISE (Walking Instruction based on Self-Efficacy)