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

January 12, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Not yet recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Virginia Almadana
        • Sub-Investigator:
          • Gertrudis Sabadell
        • Sub-Investigator:
          • Patricia Guerrero
        • Sub-Investigator:
          • Maria Isabel Blasco
        • Sub-Investigator:
          • Mercedes Vaquero
        • Sub-Investigator:
          • Yolanda López
    • Alava
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
        • Sub-Investigator:
          • Pilar Cejudo
        • Sub-Investigator:
          • Teresa Elias
        • Sub-Investigator:
          • Isabel Asencio
        • Sub-Investigator:
          • Verónica Sánchez
        • Sub-Investigator:
          • Joaquin Ruiz
        • Sub-Investigator:
          • Luis Caballero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary Rehabilitation program
10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE
Behavioral: Pulmonary Rehabilitation program
Structured rehabilitation program of directed exercises
Other Names:
  • Rehabilitation program
Active Comparator: Usual care
Protocolized usual care for patient suffering PE
Other: Usual care
Usual care for patients who had suffered a Pulmonary Embolism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline up to one month after the episode of PE, final after 12 weeks of randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The day the randomization occurs and the final visit after 12 weeks of the randomization
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)
The day the randomization occurs and the final visit after 12 weeks of the randomization
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
Baseline up to one month after the episode of PE, final after 12 weeks of randomization
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)
Baseline up to one month after the episode of PE, final after 12 weeks of randomization
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)
"Baseline up to one month after the episode of PE, final after 12 weeks of randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Study Chair: Remedios Otero, MD-PhD, Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEP-RR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results to be published in impact factor journals

IPD Sharing Time Frame

After the end of analysis and publication of results

IPD Sharing Access Criteria

collaborators in the design and performance of the study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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