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Clinical Trials/NCT05824650
NCT05824650
Completed
Not Applicable

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

Hacettepe University1 site in 1 country43 target enrollmentApril 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
Hacettepe University
Enrollment
43
Locations
1
Primary Endpoint
Frailty - Loss of Strength
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2023
End Date
February 15, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ceyhun Topcuoglu

Research Assistant

Hacettepe University

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.

Outcomes

Primary Outcomes

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.

Functional capacity

Time Frame: 1 year

Individuals will be asked to walk for 6 minutes at a distance of 30 meters

Frailty - Involuntary Weight Loss

Time Frame: 1 year

Involuntary weight loss of more than 4.54 kg

Frailty - Decreased mobility

Time Frame: 1 year

It will be done with a walking test at a distance of 4 meters.

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.

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.

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

Secondary Outcomes

  • Body Composition(1 year)

Study Sites (1)

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