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

Fundación Cardiovascular de Colombia

Status: Completed

Conditions: Respiratory Muscles; Training; COPD

Treatments: Other: Respiratory muscle training

Study type: Interventional

Funder types: Other

Identifiers

NCT02935166

656656933786

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Uncharged

Placebo Comparator group

Description:

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.

Treatment:

Other: Respiratory muscle training

Inspiratory

Active Comparator group

Description:

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.

Treatment:

Other: Respiratory muscle training

Inspiratory and expiratory

Active Comparator group

Description:

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.

Treatment:

Other: Respiratory muscle training