COPD Clinical Trial
— INNOTORIOOfficial 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.
Verified date | October 2016 |
Source | Fundación Cardiovascular de Colombia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis from moderate to severe COPD muscle weakness inspiratory Must be able to do exercises Exclusion Criteria: - Positive bronchodilator response Cardiovascular, neuromuscular, or metabolic disease Hospital admission for any pathology in the last two months have completed a rehabilitation program in the last year |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundación Cardiovascular de Colombia | Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure | Defined as the ability to make a maximum respiratory effort, it was assessed using the MicroRPM® device. This test is to generate the maximum inspiratory pressure (from residual volume) and expiratory (from total lung capacity) against a road or occluded team, performing the maneuver by keeping the mouth and nose occluded. | From baseline to 3 weeks | No |
Primary | Change in Exercise Capacity assessed by cardiopulmonary exercise testing | From baseline to 3 weeks | No | |
Primary | Change in Quality of life assessed by Quality of life Short Form 36 questionnaire | From baseline to 3 weeks | No | |
Secondary | Change in Exercise Capacity assessed by Six minutes walking Test | From baseline to 3 weeks | No | |
Secondary | Change in Respiratory function assessed by spirometry | From baseline to 3 weeks | No |
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