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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-01-01

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.

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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.

Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pulmonary Rehabilitation program

10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE

Group Type EXPERIMENTAL

Pulmonary Rehabilitation program

Intervention Type BEHAVIORAL

Structured rehabilitation program of directed exercises

Usual care

Protocolized usual care for patient suffering PE

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Usual care for patients who had suffered a Pulmonary Embolism

Interventions

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Pulmonary Rehabilitation program

Structured rehabilitation program of directed exercises

Intervention Type BEHAVIORAL

Usual care

Usual care for patients who had suffered a Pulmonary Embolism

Intervention Type OTHER

Other Intervention Names

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Rehabilitation program

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

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No