NCT07065981

Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Transplant Recipient

Timeline

• Start date: 2025-06-25
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2025-07-15
• Last updated: 2025-11-19

Locations

1 site across 1 country: Turkey (Türkiye)