Congenital Heart DiseaseNCT05824650
Frailty and Non-Fragile Congenital Heart Disease
An observational study of Congenital Heart Disease and Frailty, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common… Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Congenital Heart Disease, Frailty
- What is being tested?
- Observational
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2023to 15 Feb 2024
- Phase
- Observational
- 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 15 to 45 years
- All sexes
- Child, Adult
Study population: Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. These abnormalities range from minimal defects to serious cardiovascular problems.
Who may be able to join
- Diagnosed with congenital heart disease
- To be between the ages of 15-45
- To have been informed about the study and given written consent to participate in the study.
Who cannot join
- Having a neurological, orthopedic or any systemic disease,
- Presence of infection and malignancy,
- Cognitive, psychological and mental status are not suitable for evaluations,
- To undergo another surgery other than cardiac surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Activities of Daily Living, Cognition and Muscle Strength in Individuals With Frailty and Non-Fragile Congenital Heart Disease
Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.
Read the detailed description
Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. These abnormalities cover a wide range from minimal defects to serious cardiovascular problems. The prevalence of CHD has been reported as one case per 100 live births, with increases in recent years. As a result of surgical and medical advances in recent years, childhood lethal abnormalities in previous years can be significantly alleviated and repaired. As a result of these developments, 90% of patients born with CHD are expected to survive until adulthood, and today the number of adult CHD has exceeded the number of pediatric CHD. The aging CHD population is at risk of cardiovascular disease in addition to chronic problems resulting from congenital abnormalities. Frailty was defined by the Cardiovascular Health Study Collaborative Research Group as a complex clinical syndrome resulting from cumulative declines in more than one physiological system, leading to reduced resistance to risk factors. Loss of strength, decreased physical activity, involuntary weight loss, decreased mobility, and fatigue are sub-parameters of frailty. Frailty causes common pathophysiological mechanisms with risk factors that play a role in the development of cardiovascular disease. Frailty is associated with a higher incidence of cardiovascular disease and risks of all-cause mortality, leading to a reduction in life expectancy. Cardiorespiratory fitness and functional strength are shown to be the strongest predictors of frailty level and the potential for frailty to decrease over time. It has been reported that frailty worsens cognition and activities of daily living in cardiovascular diseases. There is no study in the literature that comprehensively evaluates vulnerability in individuals with CHD. The aim of this study; To assess frailty in individuals with CHD, to compare functional capacity, muscle strength, activities of daily living, and cognition in individuals with and without CHD. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.
- Conditions
- Congenital Heart Disease, Frailty
- Being tested
- Observational
- Keywords
- Congenital Heart Disease, Frailty
- Medical subject headings
- Heart Defects, Congenital, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Individuals will be evaluated observationally in a 45-minute period in one day.
| Study group | Role | What they receive |
|---|---|---|
| Frail Congenital Heart Disease Group | Frailty Fried et al. will be evaluated according to the five-parameter criteria set in the Cardiovascular Health Study by Having 3 or more parameters positive is defined as fragility. Individuals who meet this criterion will be included in this group. Receives: Other: Observational | |
| Non-frail Congenital Heart Disease Group | Frailty Fried et al. will be evaluated according to the five-parameter criteria set in the Cardiovascular Health Study by Having 3 or more parameters positive is defined as fragility. Individuals who do not meet this criterion will be included in this group. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty - Involuntary Weight Loss
Involuntary weight loss of more than 4.54 kg
Measured: 1 year
Frailty - Loss of Strength
Grip strength will be evaluated using a grip dynamometer.
Measured: 1 year
Frailty - International Physical Activity Questionnaire-Short Form
Physical activity assessment will be evaluated with the International Physical Activity Questionnaire-Short Form. The higher the score, the higher the physical activity; A low score indicates physical activity.
Measured: 1 week
Frailty - Decreased mobility
It will be done with a walking test at a distance of 4 meters.
Measured: 1 year
Frailty - Center for Epidemiologic Studies Depression Scale (CES-D).
Exhaustion was assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). High scores indicate increased exhaustion; low scores indicate decreased exhaustion.
Measured: 1 year
Functional capacity
Individuals will be asked to walk for 6 minutes at a distance of 30 meters
Measured: 1 year
Peripheral Muscle Strength
Knee extensor and shoulder abductor muscle strength will be evaluated with digital dynamometer.
Measured: 1 year
Daily Living Activities Evaluation
The Glittre Activities of Daily Living Test will be used to evaluate activities and functional status in daily life. Individuals start the test in a sitting position with backpacks weighing 5 kg for men and 2.5 kg for women. At a distance of 10 m between the chair and the shelf, when there is a 2-step ladder in the middle, patients must walk as quickly as possible and go up and down the steps, and take the one-kilogram bottles on the shelf first to the middle, then down, back to the middle, and finally up, and return, pass the step and sit on the chair. are asked to sit down and get up again, thus completing a round. Test completion time is recorded in minutes after completing five rounds
Measured: 1 year
Montreal Cognitive Assessment Test
Cognition will be assessed by the Montreal Cognitive Assessment (MoCA) test. MoCA assesses functions such as short-term memory, visuospatial skills, executive functions, abstract thinking, verbal fluency, attention, concentration, and language. The highest total score that can be obtained from the test is 30. The normal limits of the test are 21 points and above. High scores increased cognitive function; low scores indicate decreased cognitive function.
Measured: 1 year
Secondary outcomes (1)
Body Composition
The lean body mass percentage of the individual will be determined by Bioelectrical Impedance Analysis. The measurement will be made by the individual standing on the device with bare feet and waiting. If the lean body mass percentage values are in the normal range, the body composition is normal; lean body mass percentage low values indicate deterioration of body composition.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start20 Apr 2023
- Primary completion15 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Topcuoglu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824650
- Sponsor's protocol ID
- GO 23/20
- Status last verified
- May 2024
- First submitted
- 29 Mar 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Activities of Daily Living, Cognition and Muscle Strength in Individuals With Frailty and Non-Fragile Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT05824650
- Acronym / sponsor ID
- GO 23/20
- Conditions
- Congenital Heart Disease, Frailty
- Keywords
- Congenital Heart Disease, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 21 Apr 2023 (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.
Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.
Detailed description
Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. These abnormalities cover a wide range from minimal defects to serious cardiovascular problems. The prevalence of CHD has been reported as one case per 100 live births, with increases in recent years. As a result of surgical and medical advances in recent years, childhood lethal abnormalities in previous years can be significantly alleviated and repaired. As a result of these developments, 90% of patients born with CHD are expected to survive until adulthood, and today the number of adult CHD has exceeded the number of pediatric CHD. The aging CHD population is at risk of cardiovascular disease in addition to chronic problems resulting from congenital abnormalities. Frailty was defined by the Cardiovascular Health Study Collaborative Research Group as a complex clinical syndrome resulting from cumulative declines in more than one physiological system, leading to reduced resistance to risk factors. Loss of strength, decreased physical activity, involuntary weight loss, decreased mobility, and fatigue are sub-parameters of frailty. Frailty causes common pathophysiological mechanisms with risk factors that play a role in the development of cardiovascular disease. Frailty is associated with a higher incidence of cardiovascular disease and risks of all-cause mortality, leading to a reduction in life expectancy. Cardiorespiratory fitness and functional strength are shown to be the strongest predictors of frailty level and the potential for frailty to decrease over time. It has been reported that frailty worsens cognition and activities of daily living in cardiovascular diseases. There is no study in the literature that comprehensively evaluates vulnerability in individuals with CHD. The aim of this study; To assess frailty in individuals with CHD, to compare functional capacity, muscle strength, activities of daily living, and cognition in individuals with and without CHD. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail Congenital Heart Disease Group | – | Other: ObservationalFrailty Fried et al. will be evaluated according to the five-parameter criteria set in the Cardiovascular Health Study by Having 3 or more parameters positive is defined as fragility. Individuals who meet this criterion will be included in this group. |
| Non-frail Congenital Heart Disease Group | – | Other: ObservationalFrailty Fried et al. will be evaluated according to the five-parameter criteria set in the Cardiovascular Health Study by Having 3 or more parameters positive is defined as fragility. Individuals who do not meet this criterion will be included in this group. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. These abnormalities range from minimal defects to serious cardiovascular problems.
Key inclusion criteria (3 listed)
- Diagnosed with congenital heart disease
- To be between the ages of 15-45
- To have been informed about the study and given written consent to participate in the study.
Key exclusion criteria (4 listed)
- Having a neurological, orthopedic or any systemic disease,
- Presence of infection and malignancy,
- Cognitive, psychological and mental status are not suitable for evaluations,
- To undergo another surgery other than cardiac surgery.
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 |
|---|---|---|
| ObservationalIndividuals will be evaluated observationally in a 45-minute period in one day. | Other | Frail Congenital Heart Disease Group, Non-frail Congenital Heart Disease Group |
Primary outcome
Frailty - Involuntary Weight Loss
Time frame: 1 year
Involuntary weight loss of more than 4.54 kg
Frailty - Loss of Strength
Time frame: 1 year
Grip strength will be evaluated using a grip dynamometer.
Frailty - International Physical Activity Questionnaire-Short Form
Time frame: 1 week
Physical activity assessment will be evaluated with the International Physical Activity Questionnaire-Short Form. The higher the score, the higher the physical activity; A low score indicates physical activity.
Frailty - Decreased mobility
Time frame: 1 year
It will be done with a walking test at a distance of 4 meters.
Frailty - Center for Epidemiologic Studies Depression Scale (CES-D).
Time frame: 1 year
Exhaustion was assessed by the Center for Epidemiologic Studies Depression Scale (CES-D). High scores indicate increased exhaustion; low scores indicate decreased exhaustion.
Functional capacity
Time frame: 1 year
Individuals will be asked to walk for 6 minutes at a distance of 30 meters
Peripheral Muscle Strength
Time frame: 1 year
Knee extensor and shoulder abductor muscle strength will be evaluated with digital dynamometer.
Daily Living Activities Evaluation
Time frame: 1 year
The Glittre Activities of Daily Living Test will be used to evaluate activities and functional status in daily life. Individuals start the test in a sitting position with backpacks weighing 5 kg for men and 2.5 kg for women. At a distance of 10 m between the chair and the shelf, when there is a 2-step ladder in the middle, patients must walk as quickly as possible and go up and down the steps, and take the one-kilogram bottles on the shelf first to the middle, then down, back to the middle, and finally up, and return, pass the step and sit on the chair. are asked to sit down and get up again, thus completing a round. Test completion time is recorded in minutes after completing five rounds
Montreal Cognitive Assessment Test
Time frame: 1 year
Cognition will be assessed by the Montreal Cognitive Assessment (MoCA) test. MoCA assesses functions such as short-term memory, visuospatial skills, executive functions, abstract thinking, verbal fluency, attention, concentration, and language. The highest total score that can be obtained from the test is 30. The normal limits of the test are 21 points and above. High scores increased cognitive function; low scores indicate decreased cognitive function.
1 secondary outcome
Body Composition
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 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?
An observational study of Congenital Heart Disease and Frailty, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 16 May 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 - Involuntary Weight Loss (time frame: 1 year). The study lists 9 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 16 May 2024.