Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 144
- Locations
- 6
- Primary Endpoint
- Change in the rate of lung perfusion defects after PE
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in the rate of lung perfusion defects after PE
Time Frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Lung scintigraphy of lung perfusion
Secondary Outcomes
- 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)