Move With Air: Physiological Response Assessment

NCT05659550 | Recruiting

• 1 other identifier: FanEx_2023-9286
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Heart Failure

Keywords

Breathlessness; Dyspnea; Exercise; Fan-to-face therapy; Physiological Mechanisms; Constant work rate exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cardiopulmonary exercise test (4-minute constant rate) physiological response (ventilatory)

  Averaged across the 4-minute constant rate treadmill test

• Cardiopulmonary exercise test (4-minute constant rate) physiological response (operating lung volumes)

  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)

  Averaged across the 4-minute constant rate treadmill test

• Cardiopulmonary exercise test (3-minute constant rate) physiological response (oxygen saturation)

  Averaged across the 4-minute constant rate treadmill test

Study Arms (3)

Fan-to-face

EXPERIMENTAL

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

Fan-to-leg

SHAM COMPARATOR

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

No fan

NO INTERVENTION

The participants will complete a 4-minute constant work rate treadmill test with no fan.

Interventions

Honeywell HT-900 Turbo Force Air Circulator DEVICE

This is a basic, portable, household fan with a single cost of CDN$21.99.

Also known as: Fan

Fan-to-face; Fan-to-leg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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'.

You may not qualify if:

• 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).

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

Centre of Innovative Medicine of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Heart Failure; Dyspnea; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Study Officials

• Dennis Jensen, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachelle I Aucoin, PhD Student

CONTACT

514-398-4184; rachelle.aucoin@mail.mcgill.ca

Dennis Jensen, PhD

CONTACT

514-398-4148; dennis.jensen@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Each participant will complete the same constant work rate exercise test under three random-order experiemental conditions.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: April 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)