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

NCT ID: NCT02935166

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-01-31

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.

Conditions

COPD; Respiratory Muscles; Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Uncharged

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.

Group Type: PLACEBO_COMPARATOR

Respiratory muscle training

Intervention Type: OTHER

General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.

Inspiratory

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.

Group Type: ACTIVE_COMPARATOR

Respiratory muscle training

Intervention Type: OTHER

General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.

Inspiratory and expiratory

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.

Group Type: ACTIVE_COMPARATOR

Respiratory muscle training

Intervention Type: OTHER

General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.

Interventions

Respiratory muscle training

General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

OTHER_GOV

Sponsor Role: collaborator

Fundación Cardiovascular de Colombia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

656656933786

Identifier Type: -

Identifier Source: org_study_id