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Completed

NCT Number: NCT05376605

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

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.

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Key information

Conditions

Lung Transplant; Complications Disability Evaluation Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Assessment

Other

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

Primary outcomes

  1. Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS)

    Time frame: at least 3 months later post operation

    Number of sit to stands performed by patients in 1 minute

  2. Upper Lower extremity exercise capacity assessed by 6 minutes pegboard and ring test

    Time frame: at least 3 months later post operation

    the number of rings that was moved from the lower pegs to the upper pegs and vice-versa, during a six-minute period

  3. Dyspnea assessed by mMRC dyspnea scale

    Time frame: at least 3 months later post operation

    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

Secondary outcomes

  1. Sleep quality assessed by Pittsburgh sleep quality index

    Time frame: at least 3 months later post operation

    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

  2. comorbidity level assessed by Charlson comorbidity index

    Time frame: at least 3 months later post operation

    Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

ICF-Based Assessment in Lung Transplant Recipients

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 17, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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