Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
Study NCT ID:
NCT02935166
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2016-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovations in Respiratory Muscles Training in Patients With Chronic Obstructive Pulmonary Disease. (INNOTORIO)
Sponsor:
Fundación Cardiovascular de Colombia
Organization:
Study Overview
Official Title:
INNOTORIO: Innovations in the Training of the Inspiratory Muscles on Patients With Chronic Obstructive Pulmonary Disease: Design of a Digital Dual Valve and Evaluation of a New High-intensity Training Scheme of Short Duration.
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
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:
INNOTORIO
Brief Summary:
Respiratory muscle weakness and fatigue are related to clinical deterioration in patients with Chronic Obstructive Pulmonary Disease (COPD). Respiratory muscle training (RMT) is a key therapeutic strategy in these patients. It is necessary therefore to increase its dissemination on a large scale, improve patient´s adherence and optimize the control of the implementation of training. The aim of this project was to design a RMT device including light and sound incentives, digital registration application and analysis of the training sessions, and studying the effectiveness of a new shortened RMT scheme of high intensity that could provide added value to enhance the implementation of training in patients with COPD. From an operational point of view, researches were organized into three packages of complementary work focused on the design of a new portable dual valve with electronic lighting and auditory incentives components. The conceptualization and design of a software to analyze the performance and individual continuous use of the valve, and the evaluation of the feasibility, safety and efficacy of a shortened schedule of respiratory muscle training in adult patients with COPD were realized.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: