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

Primary Purpose

COPD, Respiratory Muscles, Training

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Respiratory muscle training
Sponsored by
Fundación Cardiovascular de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Uncharged

    Inspiratory

    Inspiratory and expiratory

    Arm 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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    Change in Exercise Capacity assessed by cardiopulmonary exercise testing
    Change in Quality of life assessed by Quality of life Short Form 36 questionnaire

    Secondary Outcome Measures

    Change in Exercise Capacity assessed by Six minutes walking Test
    Change in Respiratory function assessed by spirometry

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    October 14, 2016
    Sponsor
    Fundación Cardiovascular de Colombia
    Collaborators
    Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935166
    Brief Title
    Innovations in Respiratory Muscles Training in Patients With Chronic Obstructive Pulmonary Disease. (INNOTORIO)
    Acronym
    INNOTORIO
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Cardiovascular de Colombia
    Collaborators
    Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COPD, Respiratory Muscles, Training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Uncharged
    Arm Type
    Placebo Comparator
    Arm 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.
    Arm Title
    Inspiratory
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Inspiratory and expiratory
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Respiratory muscle training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in Respiratory muscle strength assessed by Maximun Respiratory Pressure
    Description
    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.
    Time Frame
    From baseline to 3 weeks
    Title
    Change in Exercise Capacity assessed by cardiopulmonary exercise testing
    Time Frame
    From baseline to 3 weeks
    Title
    Change in Quality of life assessed by Quality of life Short Form 36 questionnaire
    Time Frame
    From baseline to 3 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Exercise Capacity assessed by Six minutes walking Test
    Time Frame
    From baseline to 3 weeks
    Title
    Change in Respiratory function assessed by spirometry
    Time Frame
    From baseline to 3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

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

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