Upper Limb Exercise Capacity: Lung Transplant vs. Healthy Controls

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-25

Study Completion Date

2025-09-15

Brief Summary

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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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Detailed Description

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Conditions

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Transplant Recipient

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Individuals

No interventions assigned to this group

Lung Transplant Recipients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes