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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05376605
Other study ID # E2-21-52
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 27, 2021
Est. completion date November 11, 2021

Study information

Verified date May 2022
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was aimed to evaluate the patients undergoing lung transplantation under the International Classification of Functionality, Disability and Health (ICF) and to examine the relationships between the age at which lung transplant recipients were transplanted and recipients' comorbidity levels and body structure and functions, activity and participation level.


Description:

After lung transplantation, many complications related to various reasons are observed in patients in the long term. In this study, the severity of fatigue, limitation of daily living activities, kinesophobia, impaired sleep quality, anxiety and depression level, fragility level, balance and functional capacity in lung transplant recipients; investigators aimed to examine the relationship between the age at which the patient was transplanted and the level of comorbidity. Although there are studies on comorbidities, quality of life, daily living activities and participation level, anxiety and depression level, sleep quality, balance and physical fitness level in lung transplant recipients, kinesiophobia upper extremity functional performance in patients who have undergone lung transplantation surgery, COVID-19 infection There are no studies evaluating the anxiety associated with the disease. No study evaluating body structure functions, activity and participation level based on ICF in lung transplantation has been encountered. In our study, patients with at least 3 months past lung transplantation and without orthopedic and mental problems will be evaluated. It will be made as a single evaluation. The last pulmonary function test results of the patients, comorbidity conditions, fatigue, respiratory quality of life, coronavirus anxiety status, sleep quality, kinesophobia will be evaluated by questionnaires. Lower extremity dynamic balance and mobility will be evaluated with 1 minute sit-to-stand test, timed up and go test. Upper extremity functionality will be evaluated with a 6-minute pegboard and ring test.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date November 11, 2021
Est. primary completion date November 11, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: - At least three months have passed since the lung transplantation, without any complications at the last doctor's control - Clinically stable and, if any, accompanying comorbidities are under control - Volunteering to participate in research - Patients who do not have neurological and orthopedic problems that may prevent them from performing functional tests. Exclusion Criteria: - Single lung transplant recipient - Have orthopedic problems - Patients who cannot cooperate and adapt.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assessment
Evaluations of the patients will be made with scales, questionnaires and physical tests.

Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS) Number of sit to stands performed by patients in 1 minute at least 3 months later post operation
Primary Upper Lower extremity exercise capacity assessed by 6 minutes pegboard and ring test the number of rings that was moved from the lower pegs to the upper pegs and vice-versa, during a six-minute period at least 3 months later post operation
Primary Dyspnea assessed by mMRC dyspnea scale modified Medical Research Council (mMRC) dyspnea scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ~100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing at least 3 months later post operation
Secondary Sleep quality assessed by Pittsburgh sleep quality index The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction at least 3 months later post operation
Secondary comorbidity level assessed by Charlson comorbidity index Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. at least 3 months later post operation
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