Clincosm LogoSign in Get a demo

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

Sponsor
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04930484
Collaborator
(none)
68
Enrollment
2
Locations
5.9
Actual Duration (Months)
34
Patients Per Site
5.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    68 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cultural Adaptation, Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
    Actual Study Start Date :
    Feb 3, 2021
    Actual Primary Completion Date :
    Aug 3, 2021
    Actual Study Completion Date :
    Aug 3, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Performance Measure For Activities Of Daily Living-8 [6 month]

      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.

    2. Chronic Heart Failure Questionnaire [6 month]

      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.

    3. Nothingham Health Profile [6 month]

      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.

    4. Sociodemographic data form [6 month]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nurel Akçaabat Trabzon Turkey 61100
    2 Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital Trabzon Turkey

    Sponsors and Collaborators

    • Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NUREL ERTURK, Doctora student, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04930484
    Other Study ID Numbers:
    • GO 20/1171
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by NUREL ERTURK, Doctora student, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
    Congestive heart failure
    Functional limitation
    Questionnaire
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Feb 22, 2022