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Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health

ICF-Based Assessment in Lung Transplant Recipients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05376605
Enrollment
27
Registered
2022-05-17
Start date
2021-01-27
Completion date
2021-11-11
Last updated
2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disability Evaluation, Lung Transplant; Complications

Keywords

International Classification of Functioning, Disability and Health, fatigue, functional capacity

Brief 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.

Detailed 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.

Interventions

OTHERassessment

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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS)at least 3 months later post operationNumber of sit to stands performed by patients in 1 minute
Upper Lower extremity exercise capacity assessed by 6 minutes pegboard and ring testat least 3 months later post operationthe number of rings that was moved from the lower pegs to the upper pegs and vice-versa, during a six-minute period
Dyspnea assessed by mMRC dyspnea scaleat least 3 months later post operationmodified 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

Secondary

MeasureTime frameDescription
Sleep quality assessed by Pittsburgh sleep quality indexat least 3 months later post operationThe 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
comorbidity level assessed by Charlson comorbidity indexat least 3 months later post operationCharlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026