Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8

Congestive Heart Failure Clinical Trial

Official title:

Cultural Adaptation, Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04930484
• Other study ID #: GO 20/1171
• Status: Completed
• Start date: February 3, 2021
• Est. completion date: August 3, 2021

Study information

• Verified date: February 2022
• Source: Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specific factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.1 Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF. There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.

Description:

Chronic heart failure (CHF) is characterized by limited exercise performance, which is mainly determined by disease-specifi factors, such as diminished cardiac output, abnormal ventilatory response, and low perfusion in skeletal muscles, which lead to skeletal muscle dysfunction.Exercise intolerance and symptoms may lead to activity restriction and further functional deterioration with the progression of CHF.

There is some evidence that disease-specific self-report measures more quantify clinically relevant domains than measures of general health status and are generally more sensitive to clinical change. aim of the study is to investigate the validity and reliability of the PMADL-8 questionnaire in the Turkish population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients aged between 45-75 years, who are conscious, able to answer all questions, can communicate in Turkish, diagnosed with CHF, have NYHA (New York Heart Association) heart failure functional classification II and III and agree to participate in the study will be included in the study.

Exclusion Criteria:

• CHF patients with NYHA functional class IV who were hospitalized, who are unable to cooperate, and not willing to participate.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Turkey	Nurel	Akçaabat	Trabzon
Turkey	Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital	Trabzon

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Measure For Activities Of Daily Living-8	The questionnaire consists of 8 questions. It is a daily living activities measurement questionnaire consisting of 4 categories (very easy = 1 point, easy = 2, difficult = 3 points, very difficult = 4 points). High scores indicate severe functional limitations.	6 month
Primary	Chronic Heart Failure Questionnaire	The questionnaire consists of 20 questions and four sub-dimensions. The sub-dimensions of the scale are dyspnea (5 questions), fatigue (4 questions), mood (7 questions) and dominance (4 questions). The questions have Likert-type response options ranging from 1 (worst) to 7 (best). The higher the score, the higher the quality of life.	6 month
Primary	Nothingham Health Profile	It is a general health questionnaire consisting of 6 sub-parameters consisting of energy level (ES), emotional reactions (ER), physical activity (FA), pain (A), sleep (U) and social isolation (SI) and a total of 38 items.	6 month
Primary	Sociodemographic data form	Gender, age, height, weight, body mass index, complaints, concomitant diseases, smoking and alcohol history, New York Heart Association's (NYHA) Congestive Heart Failure Classification, Coronary Artery Disease Risk Factors (Kwong et al. Circulation 2003) will be questioned. . Shortness of breath (at rest and on exertion) will be assessed with the modified Borg Scale	6 month