NCT04150003

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Embolism

Interventions

Type	Name	Description
BEHAVIORAL	Pulmonary Rehabilitation program	Structured rehabilitation program of directed exercises
OTHER	Usual care	Usual care for patients who had suffered a Pulmonary Embolism

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-11-01
• Completion: 2022-01-01
• First posted: 2019-11-04
• Last updated: 2021-01-14

Locations

3 sites across 1 country: Spain