Clinical trial NCT04150003: Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism
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
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Venous Thromboembolic Disease
Pulmonary Embolism
Rehabilitation program
Exercise training
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Change in the rate of lung perfusion defects after PE
timeFrame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Secondary outcomes:
measure: Identification of biomarkers of response to treatment
timeFrame: The day the randomization occurs and the final visit after 12 weeks of the randomization
measure: Identification of another biomarkers of response to treatment
timeFrame: The day the randomization occurs and the final visit after 12 weeks of the randomization
measure: Change in the percent predicted peak oxygen uptake (VO2 peak) after PE
timeFrame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
measure: Change in the EuroQol scale
timeFrame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
measure: Change in the PEmb-QoL questionnaire by a PEmb-QoL -
timeFrame: "Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital de Txagorritxu
state: Alava
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Remedios Otero, MD-PhD
role: STUDY_CHAIR
References: