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Move With Air: Physiological Response Assessment

Primary Purpose

Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Honeywell HT-900 Turbo Force Air Circulator
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Physiological Mechanisms, Constant work rate exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure) must report breathlessness on exertion, defined as modified Medical Research Council dyspnea scale rating ≥2 despite optimal treatment of their underlying cardiopulmonary pathophysiology according to established clinical practice guidelines have a body mass index of >18.5 kg/m2 and <35 kg/m2 must be cleared by a physician to perform physical activity/exercise following the completion of the 'Medical Clearance Form for Cardiopulmonary Exercise Testing'. Exclusion Criteria: have changed their respiratory or cardiac medication dosage and/or frequency of administration in preceding two weeks have had a disease exacerbation/hospitalization in preceding six weeks have important contraindication(s) to exercise (e.g., significant musculoskeletal or neurological disease) or pulmonary function testing (e.g., eye, chest or stomach surgery, or any history of coughing up significant amounts of blood in the previous 3 months).

Sites / Locations

  • Centre of Innovative Medicine of the McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Fan-to-face

Fan-to-leg

No fan

Arm Description

The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power output achieved on an incremental treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance so that the maximum airflow speed at the face is 4.3 meters/second.

The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power output achieved on an incremental treadmill test with a basic, portable fan placed facing the side of the lower left leg (side calf area). The fan will be placed a distance so that the maximum airflow speed at the face is 4.3 meters/second.

The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power achieved on an incremental treadmill test with no fan.

Outcomes

Primary Outcome Measures

Borg modified 0-10 category ratio scale for breathlessness intensity
Borg modified 0-10 category ratio scale will be used to assess breathlessness intensity at end-exercise of each 3-minute constant rate treadmill test under three conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A higher score is indicative of greater breathlessness, while a lower score is indicative of lesser breathlessness.

Secondary Outcome Measures

Cardiopulmonary exercise test (3-minute constant rate) physiological response (ventilatory)
Mean ventilation (Liters/minute) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater mean ventilation is indicative of a less efficient respiratory system, whereas a lower mean ventilation is indicative of a more efficient respiratory system.
Cardiopulmonary exercise test (3-minute constant rate) physiological response (operating lung volumes)
Mean operating lung volumes (i.e., inspiratory capacity in liters) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater operating lung volume (i.e., greater inspiratory capacity) is indicative of a better and more efficient breathing pattern, while a lower operating lung volume (i.e., smaller inspiratory capacity) is indicative of a worse and less efficient breathing pattern.
Cardiopulmonary exercise test (3-minute constant rate) physiological response (heart rate)
Mean heart rate (beats per minute) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower heart rate is indicative of better cardiovascular fitness, while a higher heart rate is indicative of worse cardiovascular fitness.
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
Mean oxygen saturation (in percentage) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower oxygen saturation is indicative of worse health status, while a higher oxygen saturation is indicative of better health status.

Full Information

First Posted
December 5, 2022
Last Updated
December 12, 2022
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT05659550
Brief Title
Move With Air: Physiological Response Assessment
Official Title
Move With Air: Can a Fan Reduce Exertional Breathlessness During a 3-minute Constant Rate Walking Test in Adults With Cardiopulmonary Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
June 9, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A fan blowing cool air to the face has been shown to alleviate breathlessness in malignant and non-malignant disease at rest and during exercise, however the underlying physiological mechanisms remain unknown. This random order, three-condition design study will explore physiological mechanisms of breathlessness relief with fan-to-face therapy during constant-rate exercise in people with cardiorespiratory disease.
Detailed Description
Constant work rate tests are viewed as the most suitable and sensitive method to assess exertional breathlessness. The 3-minute constant rate treadmill test (3-min CRTT) is a validated test wherein participants exercise at an intensity determined by an incremental test. For the purpose of this study, participants will perform three 3-min CRTT at 75% of peak power output, achieved during an incremental treadmill exercise test, under three experimental conditions: (i) fan to the face; (ii) fan to the leg; (iii) no fan. The order of the experimental conditions will be random for each participant. Cardiac and dynamic respiratory parameters will be collected breath-by-breath at rest and during exercise using the Hexokin Smart Shirt. In order to target the intranasal pathway located on the trigeminal nerve that is hypothesized to modulate the mechanisms governing the potential effectiveness of a fan to the face, a metabolic cart will be omitted due to the use of the facemask or mouthpiece and nasal clip that would block this pathway. Using the Borg 0-10 scale, perceptions of breathlessness intensity, unpleasantness and leg fatigue will be assessed at rest, within the last 15-seconds of each minute of exercise, and at end exercise or the symptom limited peak of exercise. Two areas of facial skin temperature, one at the forehead to target the ophthalmic branch of the trigeminal nerve and the other at the cheek to target the maxillary branch of the trigeminal nerve, will be measured prior to exercise, within the last 15-seconds of each minute of exercise, at end exercise, and following exercise using a medical grade non-contact infrared forehead thermometer. The model number of the forehead thermometer that will be used is THERMOPROPCV2 and is licensed by Health Canada and approved by the U.S. Food and Drug Administration (FDA), CE approved with European health, safety, and environmental protection standards, and approved by the Restriction of Hazardous Substances Directive (RoHS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure
Keywords
Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Physiological Mechanisms, Constant work rate exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each participant will complete the same constant work rate exercise test under three different conditions.
Masking
None (Open Label)
Masking Description
It is impossible to mask the participants or the investigator since they will be aware if the fan is pointed to the face, to the leg, or there is no fan. However, participants will not be informed of which interventional arm is suspected to be beneficial.
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fan-to-face
Arm Type
Experimental
Arm Description
The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power output achieved on an incremental treadmill test with a basic, portable fan placed in front of the face. The fan will be placed at a location to target the second and third branches of the trigeminal nerve and will be placed a distance so that the maximum airflow speed at the face is 4.3 meters/second.
Arm Title
Fan-to-leg
Arm Type
Sham Comparator
Arm Description
The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power output achieved on an incremental treadmill test with a basic, portable fan placed facing the side of the lower left leg (side calf area). The fan will be placed a distance so that the maximum airflow speed at the face is 4.3 meters/second.
Arm Title
No fan
Arm Type
No Intervention
Arm Description
The participants will complete a 3-minute constant work rate treadmill test at 75% of peak power achieved on an incremental treadmill test with no fan.
Intervention Type
Device
Intervention Name(s)
Honeywell HT-900 Turbo Force Air Circulator
Other Intervention Name(s)
Fan
Intervention Description
This is a basic, portable, household fan with a single cost of CDN$21.99.
Primary Outcome Measure Information:
Title
Borg modified 0-10 category ratio scale for breathlessness intensity
Description
Borg modified 0-10 category ratio scale will be used to assess breathlessness intensity at end-exercise of each 3-minute constant rate treadmill test under three conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A higher score is indicative of greater breathlessness, while a lower score is indicative of lesser breathlessness.
Time Frame
End-exercise of the 3-minute constant rate treadmill test
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise test (3-minute constant rate) physiological response (ventilatory)
Description
Mean ventilation (Liters/minute) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater mean ventilation is indicative of a less efficient respiratory system, whereas a lower mean ventilation is indicative of a more efficient respiratory system.
Time Frame
Averaged across the 3-minute constant rate treadmill test
Title
Cardiopulmonary exercise test (3-minute constant rate) physiological response (operating lung volumes)
Description
Mean operating lung volumes (i.e., inspiratory capacity in liters) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A greater operating lung volume (i.e., greater inspiratory capacity) is indicative of a better and more efficient breathing pattern, while a lower operating lung volume (i.e., smaller inspiratory capacity) is indicative of a worse and less efficient breathing pattern.
Time Frame
Averaged across the 3-minute constant rate treadmill test
Title
Cardiopulmonary exercise test (3-minute constant rate) physiological response (heart rate)
Description
Mean heart rate (beats per minute) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower heart rate is indicative of better cardiovascular fitness, while a higher heart rate is indicative of worse cardiovascular fitness.
Time Frame
Averaged across the 3-minute constant rate treadmill test
Title
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
Description
Mean oxygen saturation (in percentage) will be compared across the 3-minute constant rate treadmill tests under the three different conditions: (i) fan to the face; (ii) fan to the leg (sham) and; (iii) no fan (control). A lower oxygen saturation is indicative of worse health status, while a higher oxygen saturation is indicative of better health status.
Time Frame
Averaged across the 3-minute constant rate treadmill test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure) must report breathlessness on exertion, defined as modified Medical Research Council dyspnea scale rating ≥2 despite optimal treatment of their underlying cardiopulmonary pathophysiology according to established clinical practice guidelines have a body mass index of >18.5 kg/m2 and <35 kg/m2 must be cleared by a physician to perform physical activity/exercise following the completion of the 'Medical Clearance Form for Cardiopulmonary Exercise Testing'. Exclusion Criteria: have changed their respiratory or cardiac medication dosage and/or frequency of administration in preceding two weeks have had a disease exacerbation/hospitalization in preceding six weeks have important contraindication(s) to exercise (e.g., significant musculoskeletal or neurological disease) or pulmonary function testing (e.g., eye, chest or stomach surgery, or any history of coughing up significant amounts of blood in the previous 3 months).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachelle I Aucoin, PhD Student
Phone
514-398-4184
Ext
09081
Email
rachelle.aucoin@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Jensen, PhD
Phone
514-398-4148
Ext
0541
Email
dennis.jensen@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Innovative Medicine of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mcgill.ca/cerpl/
Description
Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory page

Learn more about this trial

Move With Air: Physiological Response Assessment

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