Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT04150003
Status:
UNKNOWN
Last Update Posted:
2021-01-14
First Post:
2019-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Multicenter, Randomize Study to Evaluate the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism in the Restoration Lung Perfusion
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEP-RR
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: