Frailty and Non-Fragile Congenital Heart Disease

Frailty Clinical Trial

Official title:

Investigation of Activities of Daily Living, Cognition and Muscle Strength in Individuals With Frailty and Non-Fragile Congenital Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824650
• Other study ID #: GO 23/20
• Status: Completed
• Start date: April 20, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: May 2024
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 language for all health professionals.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 15, 2024
• Est. primary completion date: January 15, 2024
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Frailty
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• Observational
Individuals will be evaluated observationally in a 45-minute period in one day.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty - Involuntary Weight Loss	Involuntary weight loss of more than 4.54 kg	1 year
Primary	Frailty - Loss of Strength	Grip strength will be evaluated using a grip dynamometer.	1 year
Primary	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.	1 week
Primary	Frailty - Decreased mobility	It will be done with a walking test at a distance of 4 meters.	1 year
Primary	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.	1 year
Primary	Functional capacity	Individuals will be asked to walk for 6 minutes at a distance of 30 meters	1 year
Primary	Peripheral Muscle Strength	Knee extensor and shoulder abductor muscle strength will be evaluated with digital dynamometer.	1 year
Primary	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	1 year
Primary	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.	1 year
Secondary	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.	1 year