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

Primary Purpose

Pulmonary Embolism

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Pulmonary Rehabilitation program

Usual care

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital de Txagorritxu
Hospital Universitario Virgen del RocioRecruiting
Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pulmonary Rehabilitation program

Usual care

Arm Description

10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE

Protocolized usual care for patient suffering PE

Outcomes

Primary Outcome Measures

Change in the rate of lung perfusion defects after PE

Lung scintigraphy of lung perfusion

Secondary Outcome Measures

Identification of biomarkers of response to treatment

Changes from baseline in the determination of mRNAs

Identification of another biomarkers of response to treatment

Changes from baseline in the determination of MPs (Microparticle (MP) Microparticles (MPs)

Change in the percent predicted peak oxygen uptake (VO2 peak) after PE

Peak Oxygen uptake (VO2 peak) is obtained from Cardiopulmonary Exercise Test

Change in the EuroQol scale

Visual analog score (0-100, lower score indicate worse outcome)

Change in the PEmb-QoL questionnaire by a PEmb-QoL -

PEmb-QoL summary score (0-100, higher score indicate worse outcome)

Full Information

NCT ID

NCT04150003

First Posted

October 22, 2019

Last Updated

January 12, 2021

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

1. Study Identification

Unique Protocol Identification Number

NCT04150003

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

November 1, 2021 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Embolism

Keywords

Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulmonary Rehabilitation program

Arm Type

Experimental

Arm Description

10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Protocolized usual care for patient suffering PE

Intervention Type

Behavioral

Intervention Name(s)

Pulmonary Rehabilitation program

Other Intervention Name(s)

Rehabilitation program

Intervention Description

Structured rehabilitation program of directed exercises

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

Usual care for patients who had suffered a Pulmonary Embolism

Primary Outcome Measure Information:

Title

Change in the rate of lung perfusion defects after PE

Description

Lung scintigraphy of lung perfusion

Time Frame

Baseline up to one month after the episode of PE, final after 12 weeks of randomization

Secondary Outcome Measure Information:

Title

Identification of biomarkers of response to treatment

Description

Changes from baseline in the determination of mRNAs

Time Frame

The day the randomization occurs and the final visit after 12 weeks of the randomization

Title

Identification of another biomarkers of response to treatment

Description

Changes from baseline in the determination of MPs (Microparticle (MP) Microparticles (MPs)

Time Frame

The day the randomization occurs and the final visit after 12 weeks of the randomization

Title

Change in the percent predicted peak oxygen uptake (VO2 peak) after PE

Description

Peak Oxygen uptake (VO2 peak) is obtained from Cardiopulmonary Exercise Test

Time Frame

Baseline up to one month after the episode of PE, final after 12 weeks of randomization

Title

Change in the EuroQol scale

Description

Visual analog score (0-100, lower score indicate worse outcome)

Time Frame

Baseline up to one month after the episode of PE, final after 12 weeks of randomization

Title

Change in the PEmb-QoL questionnaire by a PEmb-QoL -

Description

PEmb-QoL summary score (0-100, higher score indicate worse outcome)

Time Frame

"Baseline up to one month after the episode of PE, final after 12 weeks of randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Remedios Otero, Md-PHd

Phone

0034955012144

remeotero@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Clara Rosso-Fernández, MD-PhD

Phone

0034955012144

claram.rosso.sspa@juntadeandalucia.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remedios Otero, MD-PhD

Organizational Affiliation

Hospitales Universitarios Virgen del Rocío

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital de Txagorritxu

City

Vitoria

State/Province

Alava

ZIP/Postal Code

01009

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Luis Lobo, MD

joseluis.loboberistain@osakidetza.eus

Facility Name

Hospital Universitario Virgen del Rocio

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41013

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Remedios Otero, MD

remeotero@gmail.com

First Name & Middle Initial & Last Name & Degree

Pilar Cejudo

First Name & Middle Initial & Last Name & Degree

Teresa Elias

First Name & Middle Initial & Last Name & Degree

Isabel Asencio

First Name & Middle Initial & Last Name & Degree

Verónica Sánchez

First Name & Middle Initial & Last Name & Degree

Joaquin Ruiz

First Name & Middle Initial & Last Name & Degree

Luis Caballero

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Virginia Almadana

First Name & Middle Initial & Last Name & Degree

Gertrudis Sabadell

First Name & Middle Initial & Last Name & Degree

Patricia Guerrero

First Name & Middle Initial & Last Name & Degree

Maria Isabel Blasco

First Name & Middle Initial & Last Name & Degree

Mercedes Vaquero

First Name & Middle Initial & Last Name & Degree

Yolanda López

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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