Respiratory MusclesIMTNCT02243527
Respiratory Muscles and Inspiratory Muscle Training
A study testing Inspiratory Muscle Training in people with Respiratory Muscles and Breathing Exercises, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Muscles, Breathing Exercises
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Heart Lung Innovation
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: 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.
- Conditions
- Respiratory Muscles, Breathing Exercises
- Being tested
- Inspiratory Muscle Training, Sham Inspiratory Muscle Training
- Keywords
- Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
6-weeks of inspiratory muscle training
Sham Inspiratory Muscle TrainingOther
A sham training procedure that is meant to elicit no physiologic changes
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Not described Receives: Other: Inspiratory Muscle Training |
| Sham-Control Inspiratory Muscle Training | Sham comparator | Inspiratory muscle training at a low intensity meant to elicit no physiological changes. Receives: Other: Sham Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training
Secondary outcomes (1)
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).
Measured: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory MusclesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Responsible party
- Principal investigator, Jordan Guenette, University of British Columbia
- Investigators
- Jordan A Guenette, PhD, Principal investigator, University of British Columbia/Centre for Heart Lung Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243527
- Sponsor's protocol ID
- H14-00067
- Acronym
- IMT
- Status last verified
- Apr 2019
- First submitted
- 16 Sep 2014
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Respiratory Muscle Mechanics and Haemodynamics in Healthy Adults
- ClinicalTrials.gov ID
- NCT02243527
- Acronym / sponsor ID
- IMT / H14-00067
- Conditions
- Respiratory Muscles, Breathing Exercises
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Other: Inspiratory Muscle Training |
| Sham-Control Inspiratory Muscle Training | Sham comparator | Other: Sham Inspiratory Muscle TrainingInspiratory muscle training at a low intensity meant to elicit no physiological changes. |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training6-weeks of inspiratory muscle training | Other | Inspiratory Muscle Training |
| Sham Inspiratory Muscle TrainingA sham training procedure that is meant to elicit no physiologic changes | Other | Sham-Control Inspiratory Muscle Training |
Primary outcome
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).
1 secondary outcome
Accessory Respiratory Muscle Activation
Time frame: Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan A Guenette, PhD principal investigator
University of British Columbia/Centre for Heart Lung Innovation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Respiratory Muscles and Breathing Exercises, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Electromyography (time frame: Post Intervention - ie. immediately after 5 weeks of inspiratory muscle training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.