Chronic Obstructive Pulmonary DiseaseNCT05646407
Move With Air: Exercise Training Study
A study testing Honeywell HT-900 Turbo Force Air Circulator in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by McGill University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure
- What is being tested?
- Honeywell HT-900 Turbo Force Air Circulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre of Innovative Medicine of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Dennis Jensen, Ph.D., 514-398-4184 ext. 0472, dennis.jensen@mcgill.ca
About this study
Official title: Move With Air: Can a Fan Maximize the Benefits of a Supervised Exercise-training Program in Adults With Cardiopulmonary Disease?
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.
Read the detailed description
Prospective participants will complete four assessment visits (V1-V4) and 15 supervised exercise-training (T1-T15) sessions (3 sessions per week for 5 weeks). The purpose of visit 1 (V1) is twofold: 1) to screen potential participants for study eligibility; and 2) for participants identified as eligible, complete pulmonary function testing and an incremental exercise treadmill test to determine the relative intensity for visit 2 (V2). At V2, participants will undergo a dual-energy x-ray absorptiometry (DEXA) scan to assess body composition prior to the 5-week supervised exercise training. Participants will also perform an exercise endurance treadmill test at V2 performed at 75% of peak power achieved on the incremental exercise test from V1. Following V2, participants will be randomized to 5-weeks of 3x/week (total of 15 sessions) supervised exercise training to one of the two experimental conditions: (i) fan-to-face; or (ii) no fan (control). Exercise sessions will be individualized based on participants' ITT and progressed to ensure the participant is exercising at an intensity corresponding to a breathlessness intensity rating of between 3-5 Borg CR10 units and can complete at least 10 to 20-min of continuous walking. Exercise duration will be increased in 1 to 5-min intervals up to a maximum of 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline speed. Visit 3 (V3) will be done after the completion of the 5-week exercise training and will comprise of a second DEXA scan to assess for changes in body composition and the same exercise endurance test at V2 to assess for changes in exercise endurance time. Visit 4 (V4) will comprise of the same incremental exercise test as V1 to assess for changes in cardiovascular fitness.
- Being tested
- Honeywell HT-900 Turbo Force Air Circulator
- Keywords
- Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Cool air, Exercise intolerance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Heart Failure, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honeywell HT-900 Turbo Force Air CirculatorDevice
Also called Fan
This is a basic, portable, household fan with a single cost of CDN$21.99.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Pre- and post-5 week of exercise training period.
Secondary outcomes (8)
Dual-Energy X-Ray Absorptiometry-derived body composition
Dual-Energy X-Ray Absorptiometry will be used to assess changes in fat free mass pre to post supervised exercise training program. Fat free mass will be expressed as fat free max index, which is fat free mass per kg of total body weight per metre squared of standard height.
Measured: Pre- and post-5 week of exercise training period.
Cardiopulmonary exercise test physiological response (gas exchange)
Breath-by-breath cardiopulmonary exercise test (incremental) parameters will be averaged in 30-second intervals at rest and during exercise. The change in peak volume of oxygen consumption pre to post supervised exercise training will be reported.
A greater volume of oxygen consumption is indicative of a greater cardiovascular fitness
Measured: Pre- and post-5 week of exercise training period.
Cardiopulmonary exercise test physiological response (power output)
Breath-by-breath cardiopulmonary exercise test (incremental) parameters will be averaged in 30-sec intervals at rest and during exercise. The change in peak power output pre to post supervised exercise training will be reported. A greater peak power output is indicative of greater leg strength and indirectly, cardiovascular fitness.
Measured: Pre- and post-5 week of exercise training period.
Minimal clinically important difference breathlessness intensity
The proportion of participants meeting or exceeding the minimal clinically important difference of ≥1 unit on the Borg 0-10 scale in breathlessness intensity at iso-time of exercise during the cardiopulmonary exercise test (incremental) after the supervised exercise training. A greater score is indicative of worse breathlessness, while a lower score is indicative of lower breathlessness.
Measured: Pre- and post-5 week of exercise training period.
Minimal clinically important difference exercise endurance
The proportion of participants meeting or exceeding the minimal clinically important difference of ≥101-seconds for exercise endurance time at iso-time during the constant-load cardiopulmonary exercise test. The longer the exercise endurance time (greater seconds or minutes) is indicative of a greater improvement in cardiovascular fitness.
Measured: Pre- and post-5 week of exercise training period.
Modified Medical Research Council Dyspnea Scale (mMRC)
The mMRC dyspnea scale will be used to assess change in daily breathlessness pre to post supervised exercise training program. The mMRC dyspnea scale is scored from 0 to 4, where a higher score is indicative of worse daily breathlessness and a lower score is indicative of less daily breathlessness.
Measured: Pre- and post-5 week of exercise training period.
COPD Assessment Test
The COPD Assessment (CAT) Test is a validated test in chronic obstructive pulmonary disease and interstitial lung disease to assess pulmonary and extra-pulmonary symptom burden. The CAT Test will assess changes in pulmonary and extra-pulmonary symptom burden.
Measured: Pre- and post-5 week of exercise training period.
Baseline Dyspnea Index and Transition Dyspnea Index
The Baseline Dyspnea Index (BDI) and Transition Dyspnea Index (TDI) assesses breathlessness burden before and after an intervention or a certain period of time.
Measured: Pre- and post-5 week of exercise training period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646407
- Sponsor's protocol ID
- FanEx 2023-9286
- Status last verified
- Feb 2024
- First submitted
- 5 Dec 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Move With Air: Can a Fan Maximize the Benefits of a Supervised Exercise-training Program in Adults With Cardiopulmonary Disease?
- ClinicalTrials.gov ID
- NCT05646407
- Acronym / sponsor ID
- FanEx 2023-9286
- Keywords
- Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Cool air, Exercise intolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prospective participants will complete four assessment visits (V1-V4) and 15 supervised exercise-training (T1-T15) sessions (3 sessions per week for 5 weeks). The purpose of visit 1 (V1) is twofold: 1) to screen potential participants for study eligibility; and 2) for participants identified as eligible, complete pulmonary function testing and an incremental exercise treadmill test to determine the relative intensity for visit 2 (V2). At V2, participants will undergo a dual-energy x-ray absorptiometry (DEXA) scan to assess body composition prior to the 5-week supervised exercise training. Participants will also perform an exercise endurance treadmill test at V2 performed at 75% of peak power achieved on the incremental exercise test from V1. Following V2, participants will be randomized to 5-weeks of 3x/week (total of 15 sessions) supervised exercise training to one of the two experimental conditions: (i) fan-to-face; or (ii) no fan (control). Exercise sessions will be individualized based on participants' ITT and progressed to ensure the participant is exercising at an intensity corresponding to a breathlessness intensity rating of between 3-5 Borg CR10 units and can complete at least 10 to 20-min of continuous walking. Exercise duration will be increased in 1 to 5-min intervals up to a maximum of 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline speed. Visit 3 (V3) will be done after the completion of the 5-week exercise training and will comprise of a second DEXA scan to assess for changes in body composition and the same exercise endurance test at V2 to assess for changes in exercise endurance time. Visit 4 (V4) will comprise of the same incremental exercise test as V1 to assess for changes in cardiovascular fitness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Exercise training with Fan-to-face | Experimental | Device: Honeywell HT-900 Turbo Force Air CirculatorParticipants 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. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honeywell HT-900 Turbo Force Air CirculatorAlso: FanThis is a basic, portable, household fan with a single cost of CDN$21.99. | Device | Exercise training with Fan-to-face |
Primary outcome
Cardiopulmonary exercise testing endurance time
Time frame: Pre- and post-5 week of exercise training period.
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).
Borg modified 0-10 category ratio scale for breathlessness intensity
Time frame: Pre- and post-5 week of exercise training period.
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.
8 secondary outcomes
Dual-Energy X-Ray Absorptiometry-derived body composition
Time frame: Pre- and post-5 week of exercise training period.
Cardiopulmonary exercise test physiological response (gas exchange)
Time frame: Pre- and post-5 week of exercise training period.
Cardiopulmonary exercise test physiological response (power output)
Time frame: Pre- and post-5 week of exercise training period.
Minimal clinically important difference breathlessness intensity
Time frame: Pre- and post-5 week of exercise training period.
Minimal clinically important difference exercise endurance
Time frame: Pre- and post-5 week of exercise training period.
Modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: Pre- and post-5 week of exercise training period.
COPD Assessment Test
Time frame: Pre- and post-5 week of exercise training period.
Baseline Dyspnea Index and Transition Dyspnea Index
Time frame: Pre- and post-5 week of exercise training period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Jensen, PhD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honeywell HT-900 Turbo Force Air Circulator in people with Chronic Obstructive Pulmonary Disease and Interstitial Lung Disease, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachelle I Aucoin, PhD Student (514-398-4184 ext. 09081, rachelle.aucoin@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary exercise testing endurance time (time frame: Pre- and post-5 week of exercise training period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.