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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
Structured rehabilitation program of directed exercises
Usual care for patients who had suffered a Pulmonary Embolism
Hospital de Txagorritxu
Vitoria-Gasteiz, Alava, Spain
NOT_YET_RECRUITINGHospital Universitario Virgen del Rocio
Seville, Andalusia, Spain
RECRUITINGHospital Universitario Virgen Macarena
Seville, Spain
NOT_YET_RECRUITINGChange in the rate of lung perfusion defects after PE
Lung scintigraphy of lung perfusion
Time frame: Baseline up to one month after the episode of PE, final after 12 weeks of randomization
Identification of biomarkers of response to treatment
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
Identification of another biomarkers of response to treatment
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
Change in the percent predicted peak oxygen uptake (VO2 peak) after PE
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
Change in the EuroQol scale
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
Change in the PEmb-QoL questionnaire by a PEmb-QoL -
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.