Move With Air: Exercise Training Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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 20-min of continuous walking. Exercise duration will be increased in 5-min intervals up to 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.

Official Title
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Move With Air: Can a Fan Maximize the Benefits of a Supervised Exercise-training Program in Adults With Cardiopulmonary Disease?

Conditions
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Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure

Intervention / Treatment
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* Device: Honeywell HT-900 Turbo Force Air Circulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a physician diagnosis of cardiopulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, heart failure) must report breathlessness on exertion, defined as modified Medical Research Council dyspnea scale rating ≥2 despite optimal treatment of their underlying cardiopulmonary pathophysiology according to established clinical practice guidelines; 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 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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training with Fan-to-face<br>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 previous study to explore use of a fan during constant-load cycle exercise used a fan with airflow of 4.3 m/sec. An anemometer will measure the airflow from the fan, and the investigators will use this previous study as a guide when determining the appropriate airflow for the current study. | Device: Honeywell HT-900 Turbo Force Air Circulator<br>* This is a basic, portable, household fan with a single cost of CDN$21.99.<br>* Other names: Fan;|
| No Intervention: Exercise training with no fan<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise testing endurance time | Cardiopulmonary exercise testing (constant-load) will be used to assess changes in endurance time pre to post intervention. Endurance time will be defined as the total duration of loaded pedalling (minutes). | Immediately after exercise training program | 
| 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 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. | Immediately after exercise training program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediately after exercise training program | 
| 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 | Immediately after exercise training program | 
| 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. | Immediately after exercise training program | 
| 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. | Immediately after exercise training program | 
| 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. | Immediately after exercise training program | 
| Short Form Health Survey (SF-36) for quality of life | Short Form Health Survey (SF-36) will be used to assess change in quality of life pre to post supervised exercise training program. The scale for the Short Form Health Survey (SF-36) is standardized with a scoring algorithm to obtain a score ranging from 0-100, where a higher score is indicative of better health status. | Immediately after exercise training program | 
| Multidimensional Dyspnoea Profile for 'usual' breathlessness | Multidimensional Dyspnoea Profile will be used to assess change in 'usual' breathlessness pre to post supervised exercise training program. The Multidimensional Dyspnoea Profile assess the unpleasantness, intensity and feelings associated with breathlessness each using scales of 0-10, where a greater score is indicative of more unpleasantness, more intense, and more negative feelings (e.g., depressed, anxious, frustrated, etc.) associated with breathlessness. Each dimension (i.e., unpleasantness, intensity, negative feelings) scale can be assessed individually. | Immediately after exercise training program | 
| Hospital Anxiety and Depression Scale for anxiety and depressive symptoms | Hospital Anxiety and Depression Scale will be used to assess change in anxiety and depressive symptoms pre to post supervised exercise training program. There are 7 questions pertaining to depression and 7 questions pertaining to anxiety, where each question within these two sub-items has scales of 0 - 3, where there is a possible cumulative score of 21 for each sub-item. A higher score indicates higher distress, whereas a lower score indicates lesser distress. | Immediately after exercise training program | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise intolerance, Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Cool air