Clinical trial NCT05659550: Move With Air: Physiological Response Assessment
Official title: Move With Air: Can a Fan Reduce Exertional Breathlessness During a 4-minute Constant Rate Walking Test in Adults With Cardiopulmonary Disease?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Heart Failure
Keywords: Breathlessness
Dyspnea
Exercise
Fan-to-face therapy
Physiological Mechanisms
Constant work rate exercise
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will complete the same constant work rate exercise test under three random-order experiemental conditions.
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Borg modified 0-10 category ratio scale for breathlessness intensity
timeFrame: End-exercise of the 4-minute constant rate treadmill test
Secondary outcomes:
measure: Cardiopulmonary exercise test (4-minute constant rate) physiological response (ventilatory)
timeFrame: Averaged across the 4-minute constant rate treadmill test
measure: Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)
timeFrame: 4 serial dynamic inspiratory capacity maneuvers for each minute of the 4-minute constant rate treadmill test.
measure: Cardiopulmonary exercise test (4-minute constant rate) physiological response (heart rate)
timeFrame: Averaged across the 4-minute constant rate treadmill test
measure: Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)
timeFrame: Averaged across the 4-minute constant rate treadmill test
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre of Innovative Medicine of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: