Clinical trial NCT05824650: Frailty and Non-Fragile Congenital Heart Disease
Official title: Investigation of Activities of Daily Living, Cognition and Muscle Strength in Individuals With Frailty and Non-Fragile Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Frailty
Keywords: Congenital Heart Disease
Frailty
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 43
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Frailty - Involuntary Weight Loss
timeFrame: 1 year
measure: Frailty - Loss of Strength
timeFrame: 1 year
measure: Frailty - International Physical Activity Questionnaire-Short Form
timeFrame: 1 week
measure: Frailty - Decreased mobility
timeFrame: 1 year
measure: Frailty - Center for Epidemiologic Studies Depression Scale (CES-D).
timeFrame: 1 year
measure: Functional capacity
timeFrame: 1 year
measure: Peripheral Muscle Strength
timeFrame: 1 year
measure: Daily Living Activities Evaluation
timeFrame: 1 year
measure: Montreal Cognitive Assessment Test
timeFrame: 1 year
Secondary outcomes:
measure: Body Composition
timeFrame: 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: