Frailty Clinical Trial
Official title:
Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease
Verified date | September 2022 |
Source | National Yang Ming University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Yang Ming Chiao Tung University | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Yang Ming University |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | change from baseline to post-intervention at 6-week follow-up | |
Secondary | 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. | change from baseline to post-intervention at 12-week follow-up | |
Secondary | 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. | change from baseline to post-intervention at 24 week follow-up |
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