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

NCT05533346 | Withdrawn

• 1 other identifier: 202112099RINA-202200361B0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frailty

Keywords

CHD, adolescents, quality of life, walking

Outcome Measures

Primary Outcomes (3)

• Frailty Status

  The frailty phenotype and measurement method proposed by Fried et al. (2001) were modified to be suitable for use by adolescents. The five aspects of the assessment included decreased muscle strength, slow walking, thin body composition, self-reported fatigue and Decreased physical activity.

  change from baseline to post-intervention at 6-week follow-up

• Frailty Status

  The frailty phenotype and measurement method proposed by Fried et al. (2001) were modified to be suitable for use by adolescents. The five aspects of the assessment included decreased muscle strength, slow walking, thin body composition, self-reported fatigue and Decreased physical activity.

  change from baseline to post-intervention at 12-week follow-up

• Frailty Status

  The frailty phenotype and measurement method proposed by Fried et al. (2001) were modified to be suitable for use by adolescents. The five aspects of the assessment included decreased muscle strength, slow walking, thin body composition, self-reported fatigue and Decreased physical activity.

  change from baseline to post-intervention at 24-week follow-up

Secondary Outcomes (3)

• Quality of life for adolescents with congenital heart disease

  change from baseline to post-intervention at 6-week follow-up

• Quality of life for adolescents with congenital heart disease

  change from baseline to post-intervention at 12-week follow-up

• Quality of life for adolescents with congenital heart disease

  change from baseline to post-intervention at 24 week follow-up

Study Arms (2)

Experimental - with WISE

EXPERIMENTAL

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.

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

Control - without WISE

ACTIVE COMPARATOR

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.

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

Interventions

with WISE (Walking Instruction based on Self-Efficacy) BEHAVIORAL

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.

Experimental - with WISE

without WISE (Walking Instruction based on Self-Efficacy) BEHAVIORAL

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.

Control - without WISE

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

Location

MeSH Terms

Conditions

Frailty

Interventions

SOSTDC1 protein, human

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: July 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: March 22, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)