- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243527
Respiratory Muscles and Inspiratory Muscle Training (IMT)
Effects of Inspiratory Muscle Training on Respiratory Muscle Mechanics and Haemodynamics in Healthy Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6Z 1Y6
- Centre for Heart Lung Innovation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inspiratory Muscle Training
|
6-weeks of inspiratory muscle training
|
|
Sham Comparator: Sham-Control Inspiratory Muscle Training
Inspiratory muscle training at a low intensity meant to elicit no physiological changes.
|
A sham training procedure that is meant to elicit no physiologic changes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragm Electromyography
Time Frame: Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
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). |
Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accessory Respiratory Muscle Activation
Time Frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
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). |
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnoea
Time Frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
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". |
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
|
Muscle Oxygenation
Time Frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
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,
|
Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jordan A Guenette, PhD, University of British Columbia/Centre for Heart Lung Innovation
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H14-00067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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