Frailty and Non-Fragile Congenital Heart Disease

NCT05824650 | Completed DMC

• 1 other identifier: GO 23/20
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Frailty

Keywords

Congenital Heart Disease; Frailty

Outcome Measures

Primary Outcomes (9)

• Frailty - Involuntary Weight Loss

  Involuntary weight loss of more than 4.54 kg

  1 year

• Frailty - Loss of Strength

  Grip strength will be evaluated using a grip dynamometer.

  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.

  1 week

• Frailty - Decreased mobility

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

  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.

  1 year

• Functional capacity

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

  1 year

• Peripheral Muscle Strength

  Knee extensor and shoulder abductor muscle strength will be evaluated with digital dynamometer.

  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

  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.

  1 year

Secondary Outcomes (1)

• Body Composition

  1 year

Study Arms (2)

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.

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.

Other: Observational

Interventions

Observational OTHER

Individuals will be evaluated observationally in a 45-minute period in one day.

Frail Congenital Heart Disease Group; Non-frail Congenital Heart Disease Group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Frailty

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 21, 2023
• Study Start: April 20, 2023
• Primary Completion: January 15, 2024
• Study Completion: February 15, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)