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

ICF-Based Assessment in Lung Transplant Recipients

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.

Study Overview

• Status: Completed
• Conditions: Lung Transplant; Complications; Disability Evaluation
• Intervention / Treatment: Other: assessment

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lung transplant; Patients who have passed at least 3 months after lung transplantation	Other: assessment; Evaluations of the patients will be made with scales, questionnaires and physical tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Erdal Yekeler, Professor, Ankara City Hospital Bilkent; Study Director: Ebru Calik-Kutukcu, PhD, Hacettepe University Faculty of Physical Therapy and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: fatigue; functional capacity; International Classification of Functioning, Disability and Health
• Other Study ID Numbers: E2-21-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No