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

NCT05376605 | Completed

• 1 other identifier: E2-21-52
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Complications; Disability Evaluation

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Sleep quality assessed by Pittsburgh sleep quality index

  at least 3 months later post operation

• comorbidity level assessed by Charlson comorbidity index

  at least 3 months later post operation

Study Arms (1)

lung transplant

Patients who have passed at least 3 months after lung transplantation

Other: assessment

Interventions

assessment OTHER

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

lung transplant

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Single lung transplant recipient
• Have orthopedic problems
• Patients who cannot cooperate and adapt.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Erdal Yekeler, Professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Ebru Calik-Kutukcu, PhD

  Hacettepe University Faculty of Physical Therapy and Rehabilitation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 17, 2022
• Study Start: January 27, 2021
• Primary Completion: November 11, 2021
• Study Completion: November 11, 2021
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)