Effects of Combined Training Versus Aerobic Training Versus Respiratory Muscle Training in Patients With Pulmonary Hypertension: A Randomized, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 6 Minute Walking Test
研究概览
简要总结
Although there has been some progress in pharmacological management of PAH, limited functional capacity and low survival still persist, but there is evidence that exercise training can be accomplished without adverse effects or damage to cardiac function and pulmonary hemodynamics. Specifically, improvements in symptoms, exercise capacity, peripheral muscle function and quality of life. Training programs need to be better studied and well defined, and their physiological effects during physical training and functional capacity.
The aim of this study is to compare the effects of different training exercises on physical performance indicators.
详细描述
Pulmonary arterial hypertension (PAH) is characterized by pathological changes in the pulmonary vasculature which cause an increase in pulmonary vascular resistance (PVR), restricting the flow of blood through the pulmonary circulation. It is a serious illness, progressive and usually fatal which causes significant functional limitation, mainly due to dyspnea. In order to maintain the flow of blood, pulmonary artery pressure (PAP) increases and the disease progresses leading to right ventricular dysfunction and right heart failure.
Regardless of the cause of PAH, the pulmonary arteries and arterioles have reduced capacity, and increases in cardiac output during exercise is limited. As a result, the delivery of oxygen to peripheral muscles is impaired, contributing to the symptoms of fatigue and dyspnea. While the limitation of the cardiac output to meet peripheral oxygen demand during exercise largely reduces exercise capacity, musculoskeletal dysfunction may also be involved in the exercise limitation in patients with PAH. Changes such as, muscle atrophy, decreased oxidative enzymes and a greater number of type II muscle fibers lead to an early lactic acidosis and decreased functional capacity. A modest evidence exists that exercise training can be done without adverse effects or damage to cardiac and / or pulmonary hemodynamics however, the effectiveness PAH requires more research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having confirmed diagnosis of PAH, based on elevated pressure in the pulmonary artery measured by catheterization of the heart at rest, with WHO functional (World Health Organization's - Functional Assessment for Pulmonary Hypertension - modified after New York Heart Association Functional Classification (NYHA) functional classification) classes I, II, III or IV to capture PAH patients with pré-capillary involvement;
- •Clinically stable with no previous hospitalizations in the last four weeks;
- •Receiving PAH specific drug therapy for at least 3 months before the study began.
排除标准
- •Use of continuous oxygen therapy;
- •Significant musculoskeletal disease or pain / claudication members;
- •Neurologic or cognitive impairment, psychiatric disorders or psychological mood (making it difficult for patients to understand the required tests);
- •History of moderate or severe chronic lung disease;
- •PAH patients with post-capillary involvement.
- •Cardiac disease associated with cardiac failure, angina and / or unstable heart rhythm.
结局指标
主要结局
6 Minute Walking Test
时间窗: Change from Baseline to 15 weeks
Distance in meters
Incremental shuttle walking test
时间窗: Change from Baseline to 15 weeks
Distance in meters
Functional exercise capacity
时间窗: Change from Baseline to 15 weeks
Oxygen consumption measurement during cardiopulmonary test
次要结局
- Autonomic Nervous System(Change from Baseline to 15 weeks)
- Endothelial function(Change from Baseline to 15 weeks)
- Respiratory Muscle Strength(Change from Baseline to 15 weeks)
- Exhaled Nitric Oxide(Change from Baseline to 15 weeks)
- Lung function (physiological parameter)(Change from Baseline to 15 weeks)
- Musculoskeletal Function(Change from Baseline to 15 weeks)
- Physical Activity Questionnaire (IPAQ)(Change from Baseline to 15 weeks)
- Change of laboratory parameters, metabolic profile assessment and systemic inflammatory.(Change from Baseline to 15 weeks)
研究者
LUCIANA MARIA MALOSA SAMPAIO
Professor of the Postgraduate Program in Rehabilitation Sciences
University of Nove de Julho