Move With Air: Exercise Training Study

NCT05646407 | Recruiting

• 1 other identifier: FanEx 2023-9286
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the role of a stream of cool air to the face, through fan-to-face therapy, as a novel adjunct non-pharmacological therapy to enable symptomatic adults with cardiopulmonary disease to exercise at higher intensities for longer durations and maximize the psycho-physiological benefits of a supervised exercise training program. The investigators hypothesize that, compared to no fan, fan-to-face therapy will result in relatively greater improvements in exercise endurance time and intensity ratings of perceived breathlessness during constant-load cardiopulmonary exercise testing on a treadmill at 75% of peak power output following a 5-week exercise training period.

Conditions

Chronic Obstructive Pulmonary Disease; Interstitial Lung Disease; Heart Failure

Keywords

Breathlessness; Dyspnea; Exercise; Fan-to-face therapy; Cool air; Exercise intolerance

Outcome Measures

Primary Outcomes (2)

• Cardiopulmonary exercise testing endurance time

  Cardiopulmonary exercise testing (constant-load at 75% peak power output) will be used to assess changes in endurance time pre to post intervention. Endurance time will be defined as the total duration of loaded walking (minutes).

  Pre- and post-5 week of exercise training period.

• Borg modified 0-10 category ratio scale for breathlessness intensity

  Borg modified 0-10 category ratio scale will be used to assess breathlessness intensity during constant-load (75% peak power output) cardiopulmonary exercise test at iso-time, defined as the highest equivalent 2-min interval of exercise completed by a given participant during each of the constant-load cardiopulmonary exercise test. A higher score is indicative of greater breathlessness, while a lower score is indicative of lesser breathlessness.

  Pre- and post-5 week of exercise training period.

Secondary Outcomes (8)

• Dual-Energy X-Ray Absorptiometry-derived body composition

  Pre- and post-5 week of exercise training period.

• Cardiopulmonary exercise test physiological response (gas exchange)

  Pre- and post-5 week of exercise training period.

• Cardiopulmonary exercise test physiological response (power output)

  Pre- and post-5 week of exercise training period.

• Minimal clinically important difference breathlessness intensity

  Pre- and post-5 week of exercise training period.

• Minimal clinically important difference exercise endurance

  Pre- and post-5 week of exercise training period.

Study Arms (2)

Exercise training with Fan-to-face

EXPERIMENTAL

Participants randomized to the fan-to-face group will perform supervised exercise training with a basic, portable fan (Honeywell HT-900 Turbo Force Air Circulator). The fan will be placed to the front of the treadmill with airflow directed toward the area of the face innervated by the second and third branches of the trigeminal nerve. The airflow speed will be chosen by each participant so that it is most comfortable to them. An anemometer will measure the airflow from the fan.

Device: Honeywell HT-900 Turbo Force Air Circulator

Exercise training with no fan

NO INTERVENTION

Participants randomized to the no fan group will perform supervised exercise training with no fan. The exercise duration and intensity titration will follow the same format as the experimental group.

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

Exercise training with Fan-to-face

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
• be cleared to participate in a supervised exercise training program by their primary care physician

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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: It is impossible to blind the participants or the investigators for the intervention, as they will be able to see whether they have been allocated to the fan-to-face group or the no fan group. However, participants will complete the supervised exercise-training sessions alone (with the study coordinator) with no other participants in the room, therefore they will be unaware of who has been allocated to the fan-to-face group or the no fan group. They will also be kept relatively unaware of the study hypothesis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)