Lung Transplant; ComplicationsNCT05376605
Assessment of Lung Transplant Recipients Within The Scope of International Classification of Functioning, Disability and Health
An observational study of Lung Transplant; Complications and Disability Evaluation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Lung Transplant; Complications, Disability Evaluation
- What is being tested?
- assessment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2021to 11 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Single lung transplant recipient
- Have orthopedic problems
- Patients who cannot cooperate and adapt.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- assessment
- Keywords
- International Classification of Functioning, Disability and Health, fatigue, functional capacity
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessmentOther
Evaluations of the patients will be made with scales, questionnaires and physical tests.
| Study group | Role | What they receive |
|---|---|---|
| lung transplant | Patients who have passed at least 3 months after lung transplantation Receives: Other: assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS)
Number of sit to stands performed by patients in 1 minute
Measured: 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
Measured: 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
Measured: at least 3 months later post operation
Secondary outcomes (2)
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
Measured: 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.
Measured: at least 3 months later post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start27 Jan 2021
- Primary completion11 Nov 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulaş Ar, Ankara City Hospital Bilkent
- Investigators
- Erdal Yekeler, Professor, Principal investigator, Ankara City Hospital BilkentEbru Calik-Kutukcu, PhD, Study director, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376605
- Sponsor's protocol ID
- E2-21-52
- Status last verified
- Oct 2024
- First submitted
- 6 May 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICF-Based Assessment in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT05376605
- Acronym / sponsor ID
- E2-21-52
- Keywords
- International Classification of Functioning, Disability and Health, fatigue, functional capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung transplant | – | Other: assessmentPatients who have passed at least 3 months after lung transplantation |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Single lung transplant recipient
- Have orthopedic problems
- Patients who cannot cooperate and adapt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessmentEvaluations of the patients will be made with scales, questionnaires and physical tests. | Other | lung transplant |
Primary outcome
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
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
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
2 secondary outcomes
Sleep quality assessed by Pittsburgh sleep quality index
Time frame: at least 3 months later post operation
comorbidity level assessed by Charlson comorbidity index
Time frame: at least 3 months later post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdal Yekeler, Professor principal investigator
Ankara City Hospital Bilkent
Ebru Calik-Kutukcu, PhD study director
Hacettepe University Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant; Complications and Disability Evaluation, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity exercise capacity assessed by 1 minute sit to stand test (STS) (time frame: at least 3 months later post operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.