Frailty and Non-Fragile Congenital Heart Disease

NCT ID: NCT05824650

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2024-02-15

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.

Conditions

Congenital Heart Disease; Frailty

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observational

Intervention Type: OTHER

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

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.

Observational

Intervention Type: OTHER

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

Interventions

Observational

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Ceyhun Topcuoglu

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 23/20

Identifier Type: -

Identifier Source: org_study_id