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Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism (TEP-RR)

F

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status

Unknown

Conditions

Pulmonary Embolism

Treatments

Behavioral: Pulmonary Rehabilitation program
Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

144 participants in 2 patient groups

Pulmonary Rehabilitation program
Experimental group
Description:
10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE
Treatment:
Behavioral: Pulmonary Rehabilitation program
Usual care
Active Comparator group
Description:
Protocolized usual care for patient suffering PE
Treatment:
Other: Usual care

Trial contacts and locations

3

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Central trial contact

Remedios Otero, Md-PHd; Clara Rosso-Fernández, MD-PhD

Data sourced from clinicaltrials.gov

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