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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 1, 2021

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.

Interventions

  • Behavioral: Pulmonary Rehabilitation program
    • Structured rehabilitation program of directed exercises
  • Other: Usual care
    • Usual care for patients who had suffered a Pulmonary Embolism

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Change in the rate of lung perfusion defects after PE
    • Time Frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
    • Lung scintigraphy of lung perfusion

Secondary Measures

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

Participating in This Clinical Trial

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 -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Remedios Otero, MD-PhD, Study Chair, Hospitales Universitarios Virgen del Rocío
  • Overall Contact(s)
    • Remedios Otero, Md-PHd, 0034955012144, remeotero@gmail.com

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