NCT04150003

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

October 22, 2019

Last Update Submit

January 12, 2021

Conditions

Pulmonary Embolism

Keywords

Venous Thromboembolic DiseasePulmonary EmbolismRehabilitation programExercise training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Identification of biomarkers of response to treatment

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

  • Identification of another biomarkers of response to treatment

    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

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

  • Change in the EuroQol scale

    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 -

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

Study Arms (2)

Pulmonary Rehabilitation program

EXPERIMENTAL

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

Behavioral: Pulmonary Rehabilitation program

Usual care

ACTIVE COMPARATOR

Protocolized usual care for patient suffering PE

Other: Usual care

Interventions

Pulmonary Rehabilitation programBEHAVIORAL

Structured rehabilitation program of directed exercises

Also known as: Rehabilitation program
Pulmonary Rehabilitation program
Usual careOTHER

Usual care for patients who had suffered a Pulmonary Embolism

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital de Txagorritxu

Vitoria-Gasteiz, Alava, 01009, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocio

Seville, Andalusia, 41013, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Remedios Otero, MD-PhD

    Hospitales Universitarios Virgen del Rocío

    STUDY CHAIR

Central Study Contacts

Remedios Otero, Md-PHd

CONTACT

0034955012144remeotero@gmail.com

Clara Rosso-Fernández, MD-PhD

CONTACT

0034955012144claram.rosso.sspa@juntadeandalucia.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

November 4, 2019

Study Start

November 1, 2019

Primary Completion

November 1, 2021

Study Completion

January 1, 2022

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Results to be published in impact factor journals

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After the end of analysis and publication of results
Access Criteria
collaborators in the design and performance of the study

Locations

ES(3)