Pulmonary Embolism
Conditions
Keywords
Venous Thromboembolic Disease, Pulmonary Embolism, Rehabilitation program, Exercise training
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.
Interventions
BEHAVIORALPulmonary Rehabilitation program
Structured rehabilitation program of directed exercises
OTHERUsual care
Usual care for patients who had suffered a Pulmonary Embolism
Sponsors
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the rate of lung perfusion defects after PE | Baseline up to one month after the episode of PE, final after 12 weeks of randomization | Lung scintigraphy of lung perfusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identification of biomarkers of response to treatment | 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 | 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 | 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 | 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 - | 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) |
Countries
Spain
Contacts
Primary ContactRemedios Otero, Md-PHd
Backup ContactClara Rosso-Fernández, MD-PhD
Outcome results
None listed