Comparison of Upper Extremity Functional Exercise Capacity Between Lung Transplant Recipients and Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Upper extremity functional exercise capacity
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Upper extremity functional exercise capacity
时间窗: 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
次要结局
- Respiratory Function(Baseline only (no follow-up))