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

Primary Purpose

Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
with WISE (Walking Instruction based on Self-Efficacy)
without WISE (Walking Instruction based on Self-Efficacy)
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frailty focused on measuring CHD, adolescents, quality of life, walking

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • National Yang Ming Chiao Tung University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental - with WISE

Control - without WISE

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Quality of life for adolescents with congenital heart disease
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.
Quality of life for adolescents with congenital heart disease
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.
Quality of life for adolescents with congenital heart disease
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.

Full Information

First Posted
September 6, 2022
Last Updated
September 11, 2022
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05533346
Brief Title
Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With CHD
Official Title
Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty
Keywords
CHD, adolescents, quality of life, walking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental - with WISE
Arm Type
Experimental
Arm 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.
Arm Title
Control - without WISE
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
with WISE (Walking Instruction based on Self-Efficacy)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
without WISE (Walking Instruction based on Self-Efficacy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frailty Status
Description
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.
Time Frame
change from baseline to post-intervention at 6-week follow-up
Title
Frailty Status
Description
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.
Time Frame
change from baseline to post-intervention at 12-week follow-up
Title
Frailty Status
Description
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.
Time Frame
change from baseline to post-intervention at 24-week follow-up
Secondary Outcome Measure Information:
Title
Quality of life for adolescents with congenital heart disease
Description
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.
Time Frame
change from baseline to post-intervention at 6-week follow-up
Title
Quality of life for adolescents with congenital heart disease
Description
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.
Time Frame
change from baseline to post-intervention at 12-week follow-up
Title
Quality of life for adolescents with congenital heart disease
Description
Quality of life scale for adolescents with congenital heart disease (PedsQLTM 3.0 Cardiac Module) will be used to measure participant's quality of life. This scale is divided into five aspects for measurement, including disease status, physical appearance, treatment anxiety, cognitive status and communication ability assessment. Those who take heart disease medicines must answer a total of 27 questions; those who do not take heart disease medicines have 22 questions, and each question has five options. 1 point for "yes", 2 points for "sometimes", 3 points for "often", and 4 points for "almost always". The lower the score, the better the quality of life.
Time Frame
change from baseline to post-intervention at 24 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chi-Wen Chen, PhD
Phone
02-28267348
Email
chiwenchen@ym.edu.tw
Facility Information:
Facility Name
National Yang Ming Chiao Tung University
City
Taipei
ZIP/Postal Code
11221
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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