Move With Air: Physiological Response Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Move With Air: Exercise Training Study

NCT05646407

Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Heart Failure

RECRUITING NA

Effectiveness of a Hand-held Fan for Breathlessness

NCT01123902

Primary Lung Cancer or Secondary Lung Metastases COPD III/IV

COMPLETED PHASE2

Aerosure and Six Minute Walk Distance in Severe COPD

NCT02007590

COPD

COMPLETED NA

Physiological Effects of HFNC During Exercise in Patients With Fibrosing Interstitial Lung Diseases

NCT05372926

Interstitial Lung Disease Pulmonary Rehabilitation

UNKNOWN NA

The Use of a Handheld Fan to Manage Breathlessness - A Feasibility Study

NCT00974558

Dyspnea

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Honeywell HT-900 Turbo Force Air Circulator

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Honeywell HT-900 Turbo Force Air Circulator

Intervention Type DEVICE

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

No fan

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Honeywell HT-900 Turbo Force Air Circulator

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No