Investigation of Adults With Congenital Heart Disease in the Scope of the ICF

March 7, 2023 updated by: Tuğba Siyah, Hacettepe University

Investigation of Adults With Congenital Heart Disease in the Scope of the International Classification of Functioning, Disability, and Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Hacettepe University
        • Contact:
          • Tuğba Siyah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults with congenital heart disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Adult Congenital Heart Diseases
Other: Physiotherapy assessment
Of the individuals included in the study; Information about age, height, body weight, type of congenital heart disease, surgical history, drug use, comorbid chronic disease, education level and occupation will be obtained. Functional Capacity, Peripheral Muscular Strength, Hand Grip Strength, Fatigue, Physical Activity Level, Quality of Life, Social Participation, Depression Anxiety Stress Level and Physical Activity Barriers will be evaluated

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-minute walking test
Time Frame: December 2022- August 2023
Functional capacities of individuals will be evaluated with the 6-minute walking test (6MWT). With the 6MWT, it provides the evaluation of the functional capacities of the cardiac, respiratory and neuromuscular systems of the participants and the evaluation of the responses to exercise. For 6MWT, the start and end places of a 30-meter area will be marked, and the patients will be asked to walk this distance for 6 minutes without running at the maximum walking speed they can walk. After 6 minutes, the distance walked will be recorded in meters.
December 2022- August 2023
Peripheral Muscle Strength
Time Frame: December 2022- August 2023
Knee extensor and shoulder abductor muscle strength will be evaluated with a digital dynamometer (Lafayette, USA). Muscle strength measurements will be applied from both the right and left side extremities of the participant in triplicate and the average of the values will be recorded in kilopascals.
December 2022- August 2023
Hand Grip Strength
Time Frame: December 2022- August 2023
Maximum isometric hand grip strength will be evaluated with the electronic hand dynamometer Jamar (Performance Health; United States). Three separate measurements will be made for the right and left hands, and the average of the measurements will be recorded in kilopascals. A 20-second rest period will be given between measurements. During the evaluation, the evaluation will be made while the patient is in a sitting position with back support.
December 2022- August 2023
Evaluation of Fatigue
Time Frame: December 2022- August 2023
The effect of the fatigue levels of the participants on the functions will be evaluated with the Fatigue Severity Scale. In this scale, the participants are asked to give points between 1-7 for the questions asked considering their last week. The total score is calculated by dividing the total score by the number of questions. A score of 4 or higher usually indicates severe fatigue.
December 2022- August 2023
Physical Activity Level
Time Frame: December 2022- August 2023
The International Physical Activity Questionnaire (IPAQ) will be used to assess the physical activity level of the participants. The International Physical Activity Questionnaire (IPAQ) is a standard tool for measuring physical activity, developed by researchers from various countries with support from the World Health Organization and the Centers for Disease Control. The questionnaire is filled in the last 7 days, taking into account the physical activity level of the participants. According to the total physical activity score, the physical activity levels of the participants are classified as low, medium and high.
December 2022- August 2023
Measurement of quality of life
Time Frame: December 2022- August 2023
The quality of life of the participants will be evaluated with the Multidimensional Quality of Life Scale. The scale is a 35-item scale that covers nine sub-dimensions and each sub-dimension includes 4 items. The answers in the scale are numbered from 1 to 7. 1 is expressed as "not at all satisfied" and "7" is expressed as "very satisfied". The sub-dimensions of the questionnaire; mental health, physical health, physical function, cognitive function, sexual function, social function, productivity, access to health personnel and financial situation.
December 2022- August 2023
Evaluation of Participation
Time Frame: December 2022- August 2023
The revised form of the Community Participation Questionnaire (TKA-R) will be used to assess participation in the study. TKA-R consists of 4 sub-units as home participation, social participation, productivity, electronic social network and a total of 18 questions. Scoring focuses primarily on the frequency of performing the activity or social role, and secondly, on whether he/she does the activity alone or with family members. Questions are mostly evaluated between "0" and "2" points. The 2 points that can be taken from the questions represent a higher level of independence and social participation. The highest score that can be obtained from the survey is 35.
December 2022- August 2023
Depression Anxiety Stress
Time Frame: December 2022- August 2023
The 21-item short form of the Depression, Stress and Anxiety Scale will be used to measure the depression, anxiety and stress levels of the participants. There are 7 questions in each scale to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert Type Scale; 0 "not suitable for me", 1 "somewhat suitable for me", 2 "usually suitable for me", and 3 "completely suitable for me". An increase in the scale score indicates an increase in the level of depression, stress and anxiety.
December 2022- August 2023
Physical Activity Barriers
Time Frame: December 2022- August 2023
The Physical Activity Disability Scale for Adults will be used to identify the factors causing physical activity limitation of the participants. The Turkish version of the scale consists of 22 items. Personal barriers that cause physical activity limitation, social environment and physical environment are scored. Higher scores indicate the magnitude of barriers to physical activity.
December 2022- August 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 03032023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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