Completed

NCT Number: NCT07065981

Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

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.

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Key information

Conditions

Transplant Recipient

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for Lung Transplant Recipients:

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

Inclusion criteria

for Healthy Controls:

Aged 18-70 years
Sufficient cognitive ability to understand and complete the tests
Willing to participate in the study

Exclusion criteria

for Lung Transplant Recipients:

Single-lung transplant recipients
Patients with orthopedic limitations
Patients unable to cooperate or comply with study procedures
Patients with mental disorders

Exclusion criteria

for Healthy Controls:

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

Respiratory Function

Time frame: Baseline only (no follow-up)

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).

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of Upper Extremity Functional Exercise Capacity Between Lung Transplant Recipients and Healthy Individuals

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 15, 2025
Registry last updated: Nov 19, 2025

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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Completed