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NCT07065981

Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

Completed Last updated 19 November 2025
What this trial tests

trial in Transplant Recipient in 60 participants. Completed in 15 September 2025.

Timeline
25 June 2025
Primary endpoint
15 September 2025
15 September 2025

Quick facts

Lead sponsorAnkara City Hospital Bilkent
StatusCompleted
Study typeOBSERVATIONAL
Enrollment60
Start date25 June 2025
Primary completion15 September 2025
Estimated completion15 September 2025
Sites1 location across Turkey (Türkiye)

Conditions studied

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 18 to 70, any sex, with Transplant Recipient. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07065981.

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