NCT02243527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 years until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

September 16, 2014

Results QC Date

November 8, 2018

Last Update Submit

April 15, 2019

Conditions

Respiratory MusclesBreathing Exercises

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Accessory Respiratory Muscle Activation

    Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training

Other Outcomes (2)

  • Dyspnoea

    Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training

  • Muscle Oxygenation

    Post-intervention - ie. immediately after 5 weeks of inspiratory muscle training

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL
Other: Inspiratory Muscle Training

Sham-Control Inspiratory Muscle Training

SHAM COMPARATOR

Inspiratory muscle training at a low intensity meant to elicit no physiological changes.

Other: Sham Inspiratory Muscle Training

Interventions

Inspiratory Muscle TrainingOTHER

6-weeks of inspiratory muscle training

Inspiratory Muscle Training
Sham Inspiratory Muscle TrainingOTHER

A sham training procedure that is meant to elicit no physiologic changes

Sham-Control Inspiratory Muscle Training

Eligibility Criteria

Age19 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Heart Lung Innovation

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Jordan A. Guenette
Organization
University of British Columbia
Jordan.guenette@hli.ubc.ca
604.682.2344

Study Officials

  • Jordan A Guenette, PhD

    University of British Columbia/Centre for Heart Lung Innovation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Jordan Guenette

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 18, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 5, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-04

Locations

CA(1)