Transplant RecipientNCT07065981
Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls
An observational study of Transplant Recipient, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Lung transplantation is a surgical intervention for end-stage lung diseases (e.g., COPD, cystic fibrosis, idiopathic pulmonary fibrosis). While post-transplant pulmonary function improves, peak exercise capacity remains 40-60% lower than age-matched healthy individuals due to factors like muscle weakness, reduced… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Transplant Recipient
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jun 2025to 15 Sep 2025
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lung transplant patients who are being followed up at Bilkent City Hospital Chest Surgery Clinic
Who may be able to join
- Patients aged 18-70 years
- At least 3 months post-lung transplantation with no major complications
- Clinically stable with any comorbidities under control
- Willing to participate in the study
- No neurological or orthopedic conditions that may interfere with functional testing
- Sufficient cognitive level to understand and perform required tests and questionnaires
Show all 9Show fewer
- Aged 18-70 years
- Sufficient cognitive ability to understand and complete the tests
- Willing to participate in the study
Who cannot join
- Single-lung transplant recipients
- Patients with orthopedic limitations
- Patients unable to cooperate or comply with study procedures
- Patients with mental disorders
- Presence of cardiovascular diseases, cerebrovascular disease, dementia, chronic pulmonary diseases, moderate-to-severe liver diseases, hemiplegia, moderate or severe kidney disease, or solid tumors
- Orthopedic conditions that would prevent exercise testing Inability to cooperate or comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Upper Extremity Functional Exercise Capacity Between Lung Transplant Recipients and Healthy Individuals
Lung transplantation is a surgical intervention for end-stage lung diseases (e.g., COPD, cystic fibrosis, idiopathic pulmonary fibrosis). While post-transplant pulmonary function improves, peak exercise capacity remains 40-60% lower than age-matched healthy individuals due to factors like muscle weakness, reduced aerobic capacity, and immunosuppressive therapy. Although lower extremity rehabilitation is common, upper extremity (UE) function is often overlooked despite its impact on quality of life (QoL) and activities of daily living (ADLs). The 6-Minute Pegboard and Ring Test (6PBRT) evaluates UE functional capacity but has not been studied in long-term lung transplant recipients (LTRs).
Objectives:
Read more
Primary: Compare UE exercise capacity between LTRs and healthy controls using 6PBRT.
Secondary: Investigate correlations between 6PBRT performance and pulmonary function, fatigue perception, ADLs, and QoL in LTRs.
Hypotheses:
H0: No significant difference in UE exercise capacity between LTRs and healthy individuals.
H1: Significant difference exists.
Methods:
Design: Cross-sectional study. Sample size calculated based on prior 6PBRT data (effect size: 1.10, power: 80%, α: 0.05).
Assessments:
Demographics: Age, sex, BMI, Charlson Comorbidity Index (CCI). 6PBRT: Measures UE endurance (total rings moved in 6 minutes). Vital signs (SpO₂, heart rate, Borg scale for fatigue) recorded.
LTR-specific:
Pulmonary function: FEV₁, FVC, FEV₁/FVC. Fatigue: Fatigue Severity Scale (FSS; scores ≥4 indicate severe fatigue). QoL: St. George's Respiratory Questionnaire (SGRQ; 0=best, 100=worst). ADLs: London Chest ADL Questionnaire (0-5 scale).
Expected Outcomes:
LTRs will show significantly lower 6PBRT scores vs. controls. 6PBRT performance will correlate with pulmonary function, fatigue, and QoL in LTRs.
- Conditions
- Transplant Recipient
- Keywords
- Lung Transplant, Upper Extremity, Exercise Capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Individuals | Not described | |
| Lung Transplant Recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity functional exercise capacity
Upper Extremity Functional Capacity assessed by 6-minute pegboard and ring test (6PBRT). The 6-Minute Pegboard and Ring Test (6PBRT) assesses upper limb endurance and functional capacity. The participant moves rings between pegs on a board using alternating hands for six minutes. The total number of rings moved is recorded as the outcome
Measured: Baseline only (single assessment, no follow-up)
Secondary outcomes (1)
Respiratory Function
Respiratory functions will be evaluated with Pulmonary function tests (PFTs). Pulmonary function tests (PFTs) assess lung function. Key parameters include FEV₁, FVC, and the FEV₁/FVC ratio to evaluate airflow and detect obstruction or restriction. TLC measures total lung capacity. Results will be reported in liters (L) and as a percentage of predicted normal values (based on age, sex, and height).
Measured: Baseline only (no follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start25 Jun 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transplant RecipientStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065981
- Sponsor's protocol ID
- TABED 2-25-1288
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant confidentiality and comply with local data protection regulations.
Publications
Fuller LM, El-Ansary D, Button BM, Corbett M, Snell G, Marasco S, Holland AE. Effect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1257-1264.e2. doi: 10.1016/j.apmr.2017.09.115. Epub 2017 Oct 16.
PubMed 29042172Cakmak A, Kocaaga E, Sonbahar-Ulu H, Inal-Ince D, Vardar-Yagli N, Calik-Kutukcu E, Saglam M, Coplu L. Upper Extremity Exercise Capacity and Activities of Daily Living in Individuals With Bronchiectasis Versus Healthy Controls. Phys Ther. 2023 Apr 4;103(4):pzad012. doi: 10.1093/ptj/pzad012.
PubMed 37086209
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity Functional Exercise Capacity Between Lung Transplant Recipients and Healthy Individuals
- ClinicalTrials.gov ID
- NCT07065981
- Acronym / sponsor ID
- TABED 2-25-1288
- Conditions
- Transplant Recipient
- Keywords
- Lung Transplant, Upper Extremity, Exercise Capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 15 Jul 2025 (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.
Lung transplantation is a surgical intervention for end-stage lung diseases (e.g., COPD, cystic fibrosis, idiopathic pulmonary fibrosis). While post-transplant pulmonary function improves, peak exercise capacity remains 40-60% lower than age-matched healthy individuals due to factors like muscle weakness, reduced aerobic capacity, and immunosuppressive therapy. Although lower extremity rehabilitation is common, upper extremity (UE) function is often overlooked despite its impact on quality of life (QoL) and activities of daily living (ADLs). The 6-Minute Pegboard and Ring Test (6PBRT) evaluates UE functional capacity but has not been studied in long-term lung transplant recipients (LTRs).
Objectives:
Primary: Compare UE exercise capacity between LTRs and healthy controls using 6PBRT.
Secondary: Investigate correlations between 6PBRT performance and pulmonary function, fatigue perception, ADLs, and QoL in LTRs.
Hypotheses:
H0: No significant difference in UE exercise capacity between LTRs and healthy individuals.
H1: Significant difference exists.
Methods:
Design: Cross-sectional study. Sample size calculated based on prior 6PBRT data (effect size: 1.10, power: 80%, α: 0.05).
Assessments:
Demographics: Age, sex, BMI, Charlson Comorbidity Index (CCI). 6PBRT: Measures UE endurance (total rings moved in 6 minutes). Vital signs (SpO₂, heart rate, Borg scale for fatigue) recorded.
LTR-specific:
Pulmonary function: FEV₁, FVC, FEV₁/FVC. Fatigue: Fatigue Severity Scale (FSS; scores ≥4 indicate severe fatigue). QoL: St. George's Respiratory Questionnaire (SGRQ; 0=best, 100=worst). ADLs: London Chest ADL Questionnaire (0-5 scale).
Expected Outcomes:
LTRs will show significantly lower 6PBRT scores vs. controls. 6PBRT performance will correlate with pulmonary function, fatigue, and QoL in LTRs.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Individuals | – | – |
| Lung Transplant Recipients | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant patients who are being followed up at Bilkent City Hospital Chest Surgery Clinic
Key inclusion criteria (9 listed)
- Patients aged 18-70 years
- At least 3 months post-lung transplantation with no major complications
- Clinically stable with any comorbidities under control
- Willing to participate in the study
- No neurological or orthopedic conditions that may interfere with functional testing
Key exclusion criteria (6 listed)
- Single-lung transplant recipients
- Patients with orthopedic limitations
- Patients unable to cooperate or comply with study procedures
- Patients with mental disorders
- Presence of cardiovascular diseases, cerebrovascular disease, dementia, chronic pulmonary diseases, moderate-to-severe liver diseases, hemiplegia, moderate or severe kidney disease, or solid tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upper extremity functional exercise capacity
Time frame: Baseline only (single assessment, no follow-up)
Upper Extremity Functional Capacity assessed by 6-minute pegboard and ring test (6PBRT). The 6-Minute Pegboard and Ring Test (6PBRT) assesses upper limb endurance and functional capacity. The participant moves rings between pegs on a board using alternating hands for six minutes. The total number of rings moved is recorded as the outcome
1 secondary outcome
Respiratory Function
Time frame: Baseline only (no follow-up)
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 19 Nov 2025.
- Results publication: PubMed 29042172Fuller LM, El-Ansary D, Button BM, Corbett M, Snell G, Marasco S, Holland AE. Effect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1257-1264.e2. doi: 10.1016/j.apmr.2017.09.115. Epub 2017 Oct 16.
- Results publication: PubMed 37086209Cakmak A, Kocaaga E, Sonbahar-Ulu H, Inal-Ince D, Vardar-Yagli N, Calik-Kutukcu E, Saglam M, Coplu L. Upper Extremity Exercise Capacity and Activities of Daily Living in Individuals With Bronchiectasis Versus Healthy Controls. Phys Ther. 2023 Apr 4;103(4):pzad012. doi: 10.1093/ptj/pzad012.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant confidentiality and comply with local data protection regulations.
Related trials for Transplant Recipient
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Not yet recruiting
Full-Thickness Skin Graft Sizing and Scar Quality
Graft Healing
Recruiting
Mosaic Trial for Stem Cell Transplant Recipients
Hematologic Malignancy, Stem Cell Transplant
RecruitingPhase 2/3
CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients
Kidney Pancreas Transplantation
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplant Recipient, 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 9 inclusion and 6 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 19 Nov 2025. 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?
Upper extremity functional exercise capacity (time frame: Baseline only (single assessment, no follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07065981, which also lists 2 linked publications.
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 19 Nov 2025.