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Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
Faculdade Evangelica do Parana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, inspiratory muscles, diaphragm

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
  • In a stable condition (without exacerbations or infections for at least a month)
  • Had to be former smokers (> 6 months without smoking)
  • subjects referred by a physician to the Pulmonary Rehabilitation Program

Exclusion Criteria:

  • Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Inspiratory muscle training

    Arm Description

    The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.

    Outcomes

    Primary Outcome Measures

    Inspiratory muscle strength

    Secondary Outcome Measures

    Exercise capacity
    Dyspnea

    Full Information

    First Posted
    January 22, 2010
    Last Updated
    January 25, 2010
    Sponsor
    Faculdade Evangelica do Parana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01056081
    Brief Title
    Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease
    Official Title
    Inspiratory Muscle Training for Patients With Chronic Obstructive Pulmonary Disease Undergoing a Pulmonary Rehabilitation Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    April 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Faculdade Evangelica do Parana

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary disease. In this study the investigators investigate whether IMT associated with exercise training would be better than exercise training alone, with regard to exercise capacity, inspiratory muscle strength and dyspnea.
    Detailed Description
    Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP), exercise capacity (using six-minute walk test) and dyspnea were measured.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    COPD, inspiratory muscles, diaphragm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inspiratory muscle training
    Arm Type
    Experimental
    Arm Description
    The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.
    Intervention Type
    Other
    Intervention Name(s)
    Inspiratory muscle training
    Other Intervention Name(s)
    IMT
    Intervention Description
    The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA). The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.
    Primary Outcome Measure Information:
    Title
    Inspiratory muscle strength
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Exercise capacity
    Time Frame
    8 weeks
    Title
    Dyspnea
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects with a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) In a stable condition (without exacerbations or infections for at least a month) Had to be former smokers (> 6 months without smoking) subjects referred by a physician to the Pulmonary Rehabilitation Program Exclusion Criteria: Subjects with a known history of asthma, or severe and/or unstable heart disease or any other pathological condition that could impair their physical activities
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Silvia R Valderramas, PhD
    Organizational Affiliation
    Evangelical Faculty of Paraná
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease

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