Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

Ankara City Hospital

Status: Not yet enrolling

Conditions: Transplant Recipient

Study type: Observational

Funder types: Other

Identifiers

NCT07065981

TABED 2-25-1288

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

60 participants in 2 patient groups

Healthy Individuals

Lung Transplant Recipients