Back to resultsRespiratory Muscles and Inspiratory Muscle Training (IMT)
Primary Purpose
Respiratory Muscles, Breathing Exercises
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sham Inspiratory Muscle Training
Sponsored by
About this trial
This is an interventional basic science trial for Respiratory Muscles focused on measuring Exercise
Eligibility Criteria
Inclusion Criteria:
- Recreationally active, 'Moderate' or 'High' category on International Physical Activity Questionnaire Short form questionnaire
- Able to read and understand English
- Pulmonary function within normal limits
Exclusion Criteria:
- History of or currently smoking
- History or current symptoms of cardiopulmonary disease (including asthma and exercise induced asthma)
- Currently participating and training in a sport at a provincial, national, or international level
- Ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
- Allergies to latex or local anesthetic
- Contraindications to exercise testing
Sites / Locations
- Centre for Heart Lung Innovation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Inspiratory Muscle Training
Sham-Control Inspiratory Muscle Training
Arm Description
Inspiratory muscle training at a low intensity meant to elicit no physiological changes.
Outcomes
Primary Outcome Measures
Diaphragm Electromyography
Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).
Secondary Outcome Measures
Accessory Respiratory Muscle Activation
Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).
Full Information
NCT ID
NCT02243527
First Posted
September 16, 2014
Last Updated
April 15, 2019
Sponsor
University of British Columbia
Collaborators
Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02243527
Brief Title
Respiratory Muscles and Inspiratory Muscle Training
Acronym
IMT
Official Title
Effects of Inspiratory Muscle Training on Respiratory Muscle Mechanics and Haemodynamics in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Natural Sciences and Engineering Research Council, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The effects of inspiratory muscle training (IMT) remain controversial. Many studies have examined the effect IMT has on exercise performance, but any changes to the body that come from IMT have yet to be looked at.
This study will look at how someone breathes can change after IMT. Understanding how IMT changes the body can help us use IMT in different treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Muscles, Breathing Exercises
Keywords
Exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory Muscle Training
Arm Type
Experimental
Arm Title
Sham-Control Inspiratory Muscle Training
Arm Type
Sham Comparator
Arm Description
Inspiratory muscle training at a low intensity meant to elicit no physiological changes.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
6-weeks of inspiratory muscle training
Intervention Type
Other
Intervention Name(s)
Sham Inspiratory Muscle Training
Intervention Description
A sham training procedure that is meant to elicit no physiologic changes
Primary Outcome Measure Information:
Title
Diaphragm Electromyography
Description
Using a multipair esophageal electrode catheter we will determine any changes to the electric activity of the diaphragm.
Diaphragm electromyography (EMG) has been expressed as %max. This unit is determined as the ratio of average EMG value (uV) divided by the maximal EMG activity (uV) generated during a maximal respiratory maneuver (inspiratory capacity during exercise).
Time Frame
Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
Secondary Outcome Measure Information:
Title
Accessory Respiratory Muscle Activation
Description
Using surface electromyography to determine the activation patterns of accessory respiratory muscles (scalene and sternocleidomastoid).
Data are expressed as %max. This value is determined by taking the average electromyography (EMG) activity divided by the maximal EMG activity generated during a maximal inspiratory maneuver (inspiratory capacity during exercise).
Time Frame
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Other Pre-specified Outcome Measures:
Title
Dyspnoea
Description
Using the modified Borg scale to assess changes in perceived dyspnoea after inspiratory muscle training.
The modified Borg scale is a 0-10 category ratio scale. The floor (0) of the scale is anchored subjectively to the subjects interpretation of "no breathing discomfort at all", and the ceiling (10) to represent "the most intense breathing discomfort they have experienced or could imagine experiencing".
Time Frame
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Title
Muscle Oxygenation
Description
Using near-infrared spectroscopy to examine if there are any relative changes in concentration (∆umol/Litre) of deoxygenated hemoglobin (HHb) after training. Deoxygenated hemoglobin is used as a surrogate of oxygen extraction specific to the local vasculature of the vastus lateralis,
Time Frame
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Recreationally active, 'Moderate' or 'High' category on International Physical Activity Questionnaire Short form questionnaire
Able to read and understand English
Pulmonary function within normal limits
Exclusion Criteria:
History of or currently smoking
History or current symptoms of cardiopulmonary disease (including asthma and exercise induced asthma)
Currently participating and training in a sport at a provincial, national, or international level
Ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
Allergies to latex or local anesthetic
Contraindications to exercise testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan A Guenette, PhD
Organizational Affiliation
University of British Columbia/Centre for Heart Lung Innovation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Heart Lung Innovation
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
12. IPD Sharing Statement
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Respiratory Muscles and Inspiratory Muscle Training
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