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

Lung Transplant; Complications Clinical Trial

Official title:

ICF-Based Assessment in Lung Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376605
• Other study ID #: E2-21-52
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Disability Evaluation
• Lung Transplant; Complications

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