Clinical trial NCT05376605: Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health
Official title: ICF-Based Assessment in Lung Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant; Complications
Disability Evaluation
Keywords: International Classification of Functioning, Disability and Health
fatigue
functional capacity
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are at least 3 months past lung transplantation, who are in stable condition, and who are being followed up by the thoracic surgery clinic of the Ankara city hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS)
timeFrame: at least 3 months later post operation
measure: Upper Lower extremity exercise capacity assessed by 6 minutes pegboard and ring test
timeFrame: at least 3 months later post operation
measure: Dyspnea assessed by mMRC dyspnea scale
timeFrame: at least 3 months later post operation
Secondary outcomes:
measure: Sleep quality assessed by Pittsburgh sleep quality index
timeFrame: at least 3 months later post operation
measure: comorbidity level assessed by Charlson comorbidity index
timeFrame: at least 3 months later post operation
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Erdal Yekeler, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University Faculty of Physical Therapy and Rehabilitation
name: Ebru Calik-Kutukcu, PhD
role: STUDY_DIRECTOR
References: