FrailtyNCT05533346
Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With CHD
A study testing with WISE (Walking Instruction based on Self-Efficacy) and without WISE (Walking Instruction based on Self-Efficacy) in people with Frailty, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Frailty
- What is being tested?
- with WISE (Walking Instruction based on Self-Efficacy) and without WISE (Walking Instruction based on Self-Efficacy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2023to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease
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.
Read the 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
- Being tested
- with WISE (Walking Instruction based on Self-Efficacy), without WISE (Walking Instruction based on Self-Efficacy)
- Keywords
- CHD, adolescents, quality of life, walking
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with WISE (Walking Instruction based on Self-Efficacy)Behavioural
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.
without WISE (Walking Instruction based on Self-Efficacy)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: without WISE (Walking Instruction based on Self-Efficacy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: change from baseline to post-intervention at 24-week follow-up
Secondary outcomes (3)
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.
Measured: change from baseline to post-intervention at 6-week follow-up
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.
Measured: change from baseline to post-intervention at 12-week follow-up
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.
Measured: change from baseline to post-intervention at 24 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Jul 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Why it stopped: Based on our previous investigations, we've decided to construct a scale first.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533346
- Sponsor's protocol ID
- 202112099RINA-202200361B0
- Status last verified
- Sep 2022
- First submitted
- 6 Sep 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of WISE Program Improving Frailty Status and Quality of Life for Adolescents With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05533346
- Acronym / sponsor ID
- 202112099RINA-202200361B0
- Conditions
- Frailty
- Keywords
- CHD, adolescents, quality of life, walking
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based on our previous investigations, we've decided to construct a scale first.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - with WISE | Experimental | Behavioral: with WISE (Walking Instruction based on Self-Efficacy)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. |
| Control - without WISE | Active comparator | Behavioral: without WISE (Walking Instruction based on Self-Efficacy)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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Experimental - with WISE |
| 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. | Behavioural | Control - without WISE |
Primary outcome
Frailty Status
Time frame: change from baseline to post-intervention at 6-week follow-up
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
Time frame: change from baseline to post-intervention at 12-week follow-up
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
Time frame: change from baseline to post-intervention at 24-week follow-up
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.
3 secondary outcomes
Quality of life for adolescents with congenital heart disease
Time frame: change from baseline to post-intervention at 6-week follow-up
Quality of life for adolescents with congenital heart disease
Time frame: change from baseline to post-intervention at 12-week follow-up
Quality of life for adolescents with congenital heart disease
Time frame: change from baseline to post-intervention at 24 week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with WISE (Walking Instruction based on Self-Efficacy) and without WISE (Walking Instruction based on Self-Efficacy) in people with Frailty, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Status (time frame: change from baseline to post-intervention at 6-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.