Move With Air: Physiological Response Assessment

Move With Air: Can a Fan Reduce Exertional Breathlessness During a 4-minute Constant Rate Walking Test in Adults With Cardiopulmonary Disease?

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease
• Intervention / Treatment: Device: Honeywell HT-900 Turbo Force Air Circulator

Detailed Description

Constant work rate tests are viewed as the most suitable and sensitive method to assess exertional breathlessness. The 4-minute constant rate treadmill test (4-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 4-min CRTT under three random-order experimental conditions: (i) fan to the face; (ii) fan to the leg; (iii) no fan. The intensity of the 4-min CRTTs will be determined based on an exercise endurance test completed in a prior visit: (i) if participants have an endurance time of <3 minutes, they will do each 4-minute CRTT at 50% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 40-50% with the speed adjusted to reach 50% PPO; (ii) if participants have an exercise endurance time of 3-8 minutes, they will do each 4-minute CRTT at 75% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 60% with the speed adjusted to reach 75% PPO; (iii) if participants have an endurance time of >8 minutes, they will do each 4-minute CRTT at 90% of peak power output (PPO) achieved on the incremental exercise test, with a fixed grade incline of 70-80% with the speed adjusted to reach 90% PPO. This model is based on a recent study on selection of exercise endurance intensities in COPD.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, rating of perceived exertion, 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).

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachelle I Aucoin, PhD Student; Phone Number: 09081 514-398-4184; Email: rachelle.aucoin@mail.mcgill.ca
• Study Contact Backup: Name: Dennis Jensen, PhD; Phone Number: 0541 514-398-4148; Email: dennis.jensen@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Centre of Innovative Medicine of the McGill University Health Centre
      • Contact: Dennis Jensen, Ph.D.; Phone Number: 0472 514-398-4184; Email: dennis.jensen@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure)
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fan-to-face; The participants will complete a 4-minute constant work rate 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 chosen by the participant so that the airflow speed is comfortable.	Device: Honeywell HT-900 Turbo Force Air Circulator; This is a basic, portable, household fan with a single cost of CDN$21.99.; Other Names: Fan
Sham Comparator: Fan-to-leg; The participants will complete a 4-minute constant work rate 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 chosen by the participant so that the airflow speed is comfortable.	Device: Honeywell HT-900 Turbo Force Air Circulator; This is a basic, portable, household fan with a single cost of CDN$21.99.; Other Names: Fan
No Intervention: No fan; The participants will complete a 4-minute constant work rate treadmill test with no fan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 4-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.	End-exercise of the 4-minute constant rate treadmill test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary exercise test (4-minute constant rate) physiological response (ventilatory)	Mean ventilation (Liters/minute) will be compared across the 4-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.	Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)	Mean operating lung volumes (i.e., inspiratory capacity in liters) will be compared across the 4-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.	4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
Cardiopulmonary exercise test (4-minute constant rate) physiological response (heart rate)	Mean heart rate (beats per minute) will be compared across the 4-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.	Averaged across the 4-minute constant rate treadmill test
Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)	Mean oxygen saturation (in percentage) will be compared across the 4-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.	Averaged across the 4-minute constant rate treadmill test

Collaborators and Investigators

• Sponsor: McGill University
• Investigators: Principal Investigator: Dennis Jensen, PhD, McGill University

Publications and helpful links

Helpful Links

• Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory page

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Dyspnea; Breathlessness; Fan-to-face therapy; Physiological Mechanisms; Constant work rate exercise
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
• Other Study ID Numbers: FanEx_2023-9286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No