Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- Change in the rate of lung perfusion defects after PE
研究概览
简要总结
Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.
详细描述
An experimental multicenter study is proposed , randomized according to parallel assignation and blinded to third ones to evaluate the effect of a 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE.
Main objective is to compare the efficacy and safety in terms of quantitative measures from lung scintigraphy, of lung perfusion versus usual care in patients with PE. Additionally the study is aimed to identify bio-markers of response to treatment (mRNAs, MPs and proteomic approach) and to analyze the effects of training on exercise capacity, quality of life parameters and anxiety depression scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years or older at PE diagnosis PE diagnosis confirmed by imaging tests according guidelines Patients under correct anticoagulant treatment Persistent Lung Perfusion Defects at one month after PE diagnosis. Signed Consent Inform
排除标准
- •Incidental or silent PE Pregnant or puerperal woman Life expectancy less than 6 months Severe comorbidities (NYHA 4 in severe heart failure; COPD, gold D; severe psychiatric illness) Any disability for physical exercise according to their doctors
结局指标
主要结局
Change in the rate of lung perfusion defects after PE
时间窗: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Lung scintigraphy of lung perfusion
次要结局
- Identification of another biomarkers of response to treatment(The day the randomization occurs and the final visit after 12 weeks of the randomization)
- Change in the percent predicted peak oxygen uptake (VO2 peak) after PE(Baseline up to one month after the episode of PE, final after 12 weeks of randomization)
- Identification of biomarkers of response to treatment(The day the randomization occurs and the final visit after 12 weeks of the randomization)
- Change in the EuroQol scale(Baseline up to one month after the episode of PE, final after 12 weeks of randomization)
- Change in the PEmb-QoL questionnaire by a PEmb-QoL -("Baseline up to one month after the episode of PE, final after 12 weeks of randomization)