Clinical trial NCT05774158: Investigation of Adults With Congenital Heart Disease in the Scope of the ICF
Official title: Investigation of Adults With Congenital Heart Disease in the Scope of the International Classification of Functioning, Disability, and Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Disease
ICF
Quality of Life
Keywords: congenital heart disease
ICF
muscle strength
physical activity
quality of life
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with congenital heart disease

Brief summary: Congenital heart disease (CHD) is one of the common birth defects with a prevalence of approximately 1 in 1000 live births worldwide. While 15% of patients with CHD reached adulthood in the past, this rate is close to 90% today thanks to advancing medicine and technology.As individuals with CHD age, they may be affected by acquired cardiovascular risk factors common in the general population in addition to heart diseases such as arterial hypertension, obesity, and diabetes, increasing the risk of metabolic disease, stroke, and coronary artery disease. In addition to these risk factors, the disease affects both the social and familial environment of the patients. In addition to the mortality and morbidity of patients, which was the most important outcome measure in the past, quality of life has become the subject of current research. The International Classification of Functioning and Health (ICF) was adopted in 2001 for the use of a common, standard language and framework for describing health and health-related conditions, and is an international and standardized classification system that can evaluate functioning, disability and health holistically. There are no studies in the literature evaluating body structure, function and activity and participation in adults with congenital heart disease within the scope of ICF. Therefore, the aim of this study is; It is the evaluation of adults with CHD according to ICF sub-parameters (body structure and functions, activity and participation, and environmental factors) and the correlation of ICF parameters with other evaluation methods.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with congenital heart disease
* Being between the ages of 18-65
* 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: 6-minute walking test
timeFrame: December 2022- August 2023
measure: Peripheral Muscle Strength
timeFrame: December 2022- August 2023
measure: Hand Grip Strength
timeFrame: December 2022- August 2023
measure: Evaluation of Fatigue
timeFrame: December 2022- August 2023
measure: Physical Activity Level
timeFrame: December 2022- August 2023
measure: Measurement of quality of life
timeFrame: December 2022- August 2023
measure: Evaluation of Participation
timeFrame: December 2022- August 2023
measure: Depression Anxiety Stress
timeFrame: December 2022- August 2023
measure: Physical Activity Barriers
timeFrame: December 2022- August 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References: