Heart Failure Worsens Leg Muscle Strength and Endurance in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Cardiopulmonary function
研究概览
简要总结
The combination of heart failure (HF) and chronic obstructive pulmonary disease (COPD) is highly prevalent, but underdiagnosed and poorly recognized. It has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. In addition, it is recognized that both diseases have several mechanisms that are responsible for musculoskeletal impairment. However, the association of reduced systemic perfusion with low oxygen content observed in the association of HF and COPD may contribute to the worsening of the components of the muscle impairment cascade. Thus, muscle strength and fatigue may not only be even more altered but may also be the main determinants of functional capacity in patients with coexistence of HF and COPD. Although many studies have evaluated the muscle performance of patients with HF or COPD, the literature did not show data on worsening due to the association of the diseases. Particularities identification of the muscle impairment in the coexistence of HF and COPD is fundamental for the development of rehabilitation strategies, mainly through physical exercise. In this line, the present study tested the hypothesis that the coexistence of HF and COPD could present lower values of strength and greater fatigue. Similarly, the muscle dysfunction degree could strongly correlate with the performance markers of the incremental or functional tests in patients with HF associated with COPD.
The study protocol was reviewed and approved by the Institutional Research Board. All subjects gave written informed consent before participating in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-cachectic sedentary patients
- •moderate-to-severe COPD according to GOLD classification (FEV1/ FVC <0.7 and predicted post-bronchodilator FEV1 between 30% and 80%)
- •no clinical or echocardiographic evidence of HF for the COPD group
- •echocardiographic evidence of HF with reduced left ventricular ejection fraction (<40%) for the overlap group
- •chronic dyspnoea (MRC scale score 2-4)
- •NYHA class 2 or 3.
排除标准
- •long-term O2 therapy
- •recent (within a year) rehabilitation program
- •osteomuscular limitation
- •type I or non-controlled type II diabetes mellitus
- •peripheral arterial disease associated with claudication
- •Patients with preserved ejection fraction HF
结局指标
主要结局
Cardiopulmonary function
时间窗: one week after all tests
Exercise capacity will be assessed by the cardiopulmonary test. All data will be measured in absolute values (ml/kg) and the percentage of predicted values for the Brazilian population.
Clinical tests
时间窗: one day after all tests
Performance in clinical tests will be assessed by 6MWT and 4-min Step test. All data will be measured in absolute values.
Muscle weakness
时间窗: one week after all tests
Muscle performance will be assessed by an isokinetic dynamometer. All data will be measured in absolute values and the percentage of predicted values for the Brazilian population.
Body composition
时间窗: one day after all tests
Fat-free mass will be assessed by body composition. All data will be measured in the percentage of predicted values for the Brazilian population.
Lung Function
时间窗: one day after all tests
Clinical obstruction data will be assessed by total body plethysmography. All data will be measured in absolute values and percentage of predicted values for the Brazilian population.
Cardiac Function
时间窗: one day after all tests
An echocardiogram will be performed to assess all cardiac functions. All data will be measured in the percentage of predicted values for the Brazilian population.
次要结局
未报告次要终点
研究者
Mayron Faria de Oliveira
Clinical Investigator
Federal University of São Paulo
