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

Pulmonary Embolism Clinical Trial

— TEP-RR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04150003
• Other study ID #: TEP-RR
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Remedios Otero, Md-PHd
• Phone: 0034955012144
• Email: remeotero[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: January 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thromboembolism

Intervention

Behavioral:
• Pulmonary Rehabilitation program
Structured rehabilitation program of directed exercises

Other:
• Usual care
Usual care for patients who had suffered a Pulmonary Embolism

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocio	Sevilla	Andalucia
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital de Txagorritxu	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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