search
Back to results

Inspiratory Muscle Training Combined With General Exercise Training in COPD (IMTGET)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training with Threshold by respironics
Sham Inspiratory muscle training
Sponsored by
Hôpital Riviera-Chablais, Vaud-Valais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease

Eligibility Criteria

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

Inclusion Criteria:

  • COPD demonstrated by spirometry using Gold Criteria
  • Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey
  • Patient with maximal inspiratory pressure < 60 cmH20
  • Patient older than 40 years

Exclusion Criteria:

  • Orthopaedic or neurological troubles that could slant the 6 minute walking test

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention cohort

    Control cohort

    Arm Description

    36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.

    36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20)

    Outcomes

    Primary Outcome Measures

    Exercise capacity (six minute walking test)
    exercise capacity will be assessed by a six minute walking test

    Secondary Outcome Measures

    Quality of Life (St-George's Respiratory questionnaire)
    Quality of Life will be assessed by St-George's Respiratory questionnaire
    Maximal inspiratory pressure (MicroRPM by MicroMedical)
    Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical

    Full Information

    First Posted
    March 13, 2015
    Last Updated
    March 27, 2015
    Sponsor
    Hôpital Riviera-Chablais, Vaud-Valais
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02392715
    Brief Title
    Inspiratory Muscle Training Combined With General Exercise Training in COPD
    Acronym
    IMTGET
    Official Title
    Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hôpital Riviera-Chablais, Vaud-Valais

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.
    Detailed Description
    Prospective, parallel-group, randomized controlled trial 80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions. We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined. Patients and investigators assessing the outcomes will be blinded to group allocation. Written informed consent will be obtained from each subject. The data will be treated anonymously.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention cohort
    Arm Type
    Experimental
    Arm Description
    36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' inspiratory muscle training with Threshold by Respironics Inspiratory muscle training intensity: 15% of maximal inspiratory pressure (PiMax) during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.
    Arm Title
    Control cohort
    Arm Type
    Sham Comparator
    Arm Description
    36 sessions of 60 - 75 minutes with a frequency of 3x/week 30' endurance training, 15' strength training, 15' sham inspiratory muscle training with Threshold by Respironics Sham inspiratory muscle training intensity : 5 centimeters of water (cmH20)
    Intervention Type
    Device
    Intervention Name(s)
    Inspiratory muscle training with Threshold by respironics
    Intervention Description
    Inspiratory muscle training 15 minutes, 3x/weeks, 36 sessions Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Inspiratory muscle training
    Intervention Description
    with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)
    Primary Outcome Measure Information:
    Title
    Exercise capacity (six minute walking test)
    Description
    exercise capacity will be assessed by a six minute walking test
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Quality of Life (St-George's Respiratory questionnaire)
    Description
    Quality of Life will be assessed by St-George's Respiratory questionnaire
    Time Frame
    12 weeks
    Title
    Maximal inspiratory pressure (MicroRPM by MicroMedical)
    Description
    Inspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: COPD demonstrated by spirometry using Gold Criteria Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey Patient with maximal inspiratory pressure < 60 cmH20 Patient older than 40 years Exclusion Criteria: Orthopaedic or neurological troubles that could slant the 6 minute walking test
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stéphanie Vaudan, BSc
    Phone
    +41 24 473 18 99
    Email
    stephanie.vaudan@hopitalrivierachablais.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicolas Garin, MD
    Phone
    + 41 24 473 80 75
    Email
    nicolas.garin@hopitalrivierachablais.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stéphanie Vaudan, BSc
    Organizational Affiliation
    stephanie.vaudan@hopitalrivierachablais.ch
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Inspiratory Muscle Training Combined With General Exercise Training in COPD

    We'll reach out to this number within 24 hrs