Innovations in Respiratory Muscles Training in Patients With Chronic Obstructive Pulmonary Disease. (INNOTORIO)

Not Applicable

Completed

• Conditions: COPD; Respiratory Muscles; Training
• Interventions: Other: Respiratory muscle training

• Registration Number: NCT02935166
• Lead Sponsor: Fundación Cardiovascular de Colombia

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

Not available

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-10
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-14
• Last Update Submitted: 2016-10-14
• Study First Posted: 2016-10-17
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Uncharged	Respiratory muscle training	Respiratory muscle training: placebo General High Intensity Training (30 minutes in cycle ergometer) and placebo respiratory muscle training: This training group performed with the valve Orygen® uncharged (placebo effect). Performing 10 consecutive inspirations (5 series) two times a day during 3 weeks.
Inspiratory	Respiratory muscle training	Respiratory muscle training: Inspiratory General Training (30 minutes in cycle ergometer) and high intensity inspiratory muscle training: The inspiratory training was conducted with the Orygen® valve. Inspiratory training load was defined as maximum and patient tolerance that would perform 10 consecutive inspirations (5 series) two times a day, during 3 weeks.
Inspiratory and expiratory	Respiratory muscle training	Respiratory muscle training: Inspiratory and expiratory General High Intensity Training (30 minutes in cycle ergometer) and inspiratory and expiratory training: The inspiratory and expiratory training was conducted with the Orygen® valve. Loading inspiratory and expiratory training was defined as maximum and patient tolerance. This was the optimal load that would allow the patient to perform 10 consecutive inspirations (5 sessions) 2 times a day,during 3 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Exercise Capacity assessed by cardiopulmonary exercise testing	From baseline to 3 weeks
Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure	From baseline to 3 weeks	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.
Change in Quality of life assessed by Quality of life Short Form 36 questionnaire	From baseline to 3 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Exercise Capacity assessed by Six minutes walking Test	From baseline to 3 weeks
Change in Respiratory function assessed by spirometry	From baseline to 3 weeks