Trial Outcomes & Findings for Respiratory Muscles and Inspiratory Muscle Training (NCT NCT02243527)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

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

Results posted on

2019-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Inspiratory Muscle Training Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	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
Overall Study STARTED	12	13
Overall Study COMPLETED	12	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Inspiratory Muscle Training n=12 Participants Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	Sham-Control Inspiratory Muscle Training n=13 Participants 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	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants	13 Participants n=13 Participants	25 Participants n=25 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=25 Participants
Age, Continuous	25 years STANDARD_DEVIATION 5 • n=12 Participants	24 years STANDARD_DEVIATION 4 • n=13 Participants	24 years STANDARD_DEVIATION 4 • n=25 Participants
Sex: Female, Male Female	0 Participants n=12 Participants	0 Participants n=13 Participants	0 Participants n=25 Participants
Sex: Female, Male Male	12 Participants n=12 Participants	13 Participants n=13 Participants	25 Participants n=25 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	12 participants n=12 Participants	13 participants n=13 Participants	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Inspiratory Muscle Training n=12 Participants Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	Sham-Control Inspiratory Muscle Training n=13 Participants 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
Diaphragm Electromyography	60 %max Standard Deviation 13	55 %max Standard Deviation 13

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Inspiratory Muscle Training n=12 Participants Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	Sham-Control Inspiratory Muscle Training n=13 Participants 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
Accessory Respiratory Muscle Activation	10 %max Standard Deviation 7	6 %max Standard Deviation 4

OTHER_PRE_SPECIFIED outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Inspiratory Muscle Training n=12 Participants Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	Sham-Control Inspiratory Muscle Training n=13 Participants 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
Dyspnoea	8.5 Borg Units Standard Deviation 1.9	8.3 Borg Units Standard Deviation 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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,

Outcome measures

Outcome measures
Measure	Inspiratory Muscle Training n=12 Participants Inspiratory Muscle Training: 6-weeks of inspiratory muscle training	Sham-Control Inspiratory Muscle Training n=13 Participants 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
Muscle Oxygenation	15.9 change in umol/Litre HHb Standard Deviation 9.3	16.1 change in umol/Litre HHb Standard Deviation 10.3

Adverse Events

Inspiratory Muscle Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham-Control Inspiratory Muscle Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jordan A. Guenette

University of British Columbia

Phone: 604.682.2344

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place