NCT04930484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

February 22, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

June 11, 2021

Last Update Submit

February 21, 2022

Conditions

Congestive Heart Failure

Keywords

Congestive heart failureFunctional limitationQuestionnaire

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The sample size of the study was determined as at least 40 people, 5 times the number of items used in the scale.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nurel

Akçaabat, Trabzon, 61100, Turkey (Türkiye)

Location

Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital

Trabzon, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctora student

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 18, 2021

Study Start

February 3, 2021

Primary Completion

August 3, 2021

Study Completion

August 3, 2021

Last Updated

February 22, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)