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| Name | Class |
|---|---|
| Natural Sciences and Engineering Research Council, Canada | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training | Experimental |
| |
| Sham-Control Inspiratory Muscle Training | Sham Comparator | Inspiratory muscle training at a low intensity meant to elicit no physiological changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training | Other | 6-weeks of inspiratory muscle training |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnoea | 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". |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordan A Guenette, PhD | University of British Columbia/Centre for Heart Lung Innovation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Heart Lung Innovation | Vancouver | British Columbia | V6Z 1Y6 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inspiratory Muscle Training | Inspiratory Muscle Training: 6-weeks of inspiratory muscle training |
| FG001 | Sham-Control Inspiratory Muscle Training | Inspiratory muscle training at a low intensity meant to elicit no physiological changes. Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inspiratory Muscle Training | Inspiratory Muscle Training: 6-weeks of inspiratory muscle training |
| BG001 | Sham-Control Inspiratory Muscle Training | Inspiratory muscle training at a low intensity meant to elicit no physiological changes. Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | %max | Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training |
|
1 year
No adverse events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inspiratory Muscle Training | Inspiratory Muscle Training: 6-weeks of inspiratory muscle training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jordan A. Guenette | University of British Columbia | 604.682.2344 | 62129 | Jordan.guenette@hli.ubc.ca |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Sham Inspiratory Muscle Training |
| Other |
A sham training procedure that is meant to elicit no physiologic changes |
|
| Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training |
| Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training |
| Muscle Oxygenation | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | %max | Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training |
|
|
|
| Other Pre-specified | Dyspnoea | 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". | Posted | Mean | Standard Deviation | Borg Units | Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training |
|
|
|
| Other Pre-specified | Muscle Oxygenation | 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, | Posted | Mean | Standard Deviation | change in umol/Litre HHb | Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Sham-Control Inspiratory Muscle Training | Inspiratory muscle training at a low intensity meant to elicit no physiological changes. Sham Inspiratory Muscle Training: A sham training procedure that is meant to elicit no physiologic changes | 0 | 13 | 0 | 13 | 0 | 13 |
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