Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Behavioral: Pulmonary Rehabilitation program
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary Rehabilitation program<br>10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE | Behavioral: Pulmonary Rehabilitation program<br>* Structured rehabilitation program of directed exercises<br>* Other names: Rehabilitation program;|
| Active Comparator: Usual care<br>Protocolized usual care for patient suffering PE | Other: Usual care<br>* Usual care for patients who had suffered a Pulmonary Embolism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the rate of lung perfusion defects after PE | Lung scintigraphy of lung perfusion | Baseline up to one month after the episode of PE, final after 12 weeks of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of biomarkers of response to treatment | Changes from baseline in the determination of mRNAs | The day the randomization occurs and the final visit after 12 weeks of the randomization | 
| Identification of another biomarkers of response to treatment | Changes from baseline in the determination of MPs (Microparticle (MP) Microparticles (MPs) | 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 | Peak Oxygen uptake (VO2 peak) is obtained from Cardiopulmonary Exercise Test | Baseline up to one month after the episode of PE, final after 12 weeks of randomization | 
| Change in the EuroQol scale | Visual analog score (0-100, lower score indicate worse outcome) | 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 - | PEmb-QoL summary score (0-100, higher score indicate worse outcome) | Baseline up to one month after the episode of PE, final after 12 weeks of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training