- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04930484
Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
Cultural Adaptation, Validity and Reliability of the Turkish Version of Performance Measure for Activities of Daily Living-8
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Trabzon, Turkey
- Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital
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Trabzon
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Akçaabat, Trabzon, Turkey, 61100
- Nurel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance Measure For Activities Of Daily Living-8
Time Frame: 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.
|
6 month
|
Chronic Heart Failure Questionnaire
Time Frame: 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.
|
6 month
|
Nothingham Health Profile
Time Frame: 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.
|
6 month
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Sociodemographic data form
Time Frame: 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
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6 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 20/1171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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