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Move With Air: Exercise Training Study

Primary Purpose

Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Honeywell HT-900 Turbo Force Air Circulator
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Cool air, Exercise intolerance

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Centre of Innovative Medicine of the McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise training with Fan-to-face

Exercise training with no fan

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 5, 2022
Last Updated
December 12, 2022
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT05646407
Brief Title
Move With Air: Exercise Training Study
Official Title
Move With Air: Can a Fan Maximize the Benefits of a Supervised Exercise-training Program in Adults With Cardiopulmonary Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 9, 2023 (Anticipated)
Primary Completion Date
June 9, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease, Heart Failure
Keywords
Breathlessness, Dyspnea, Exercise, Fan-to-face therapy, Cool air, Exercise intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training with Fan-to-face
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise training with no fan
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Honeywell HT-900 Turbo Force Air Circulator
Other Intervention Name(s)
Fan
Intervention Description
This is a basic, portable, household fan with a single cost of CDN$21.99.
Primary Outcome Measure Information:
Title
Cardiopulmonary exercise testing endurance time
Description
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).
Time Frame
Immediately after exercise training program
Title
Borg modified 0-10 category ratio scale for breathlessness intensity
Description
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.
Time Frame
Immediately after exercise training program
Secondary Outcome Measure Information:
Title
Dual-Energy X-Ray Absorptiometry-derived body composition
Description
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.
Time Frame
Immediately after exercise training program
Title
Cardiopulmonary exercise test physiological response (gas exchange)
Description
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
Time Frame
Immediately after exercise training program
Title
Cardiopulmonary exercise test physiological response (power output)
Description
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.
Time Frame
Immediately after exercise training program
Title
Minimal clinically important difference breathlessness intensity
Description
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.
Time Frame
Immediately after exercise training program
Title
Minimal clinically important difference exercise endurance
Description
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.
Time Frame
Immediately after exercise training program
Title
Short Form Health Survey (SF-36) for quality of life
Description
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.
Time Frame
Immediately after exercise training program
Title
Multidimensional Dyspnoea Profile for 'usual' breathlessness
Description
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.
Time Frame
Immediately after exercise training program
Title
Hospital Anxiety and Depression Scale for anxiety and depressive symptoms
Description
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.
Time Frame
Immediately after exercise training program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachelle I Aucoin, PhD Student
Phone
514-398-4184
Ext
09081
Email
rachelle.aucoin@mail.mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Jensen, PhD
Phone
514-398-4148
Ext
0541
Email
dennis.jensen@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Jensen, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Innovative Medicine of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mcgill.ca/cerpl/
Description
Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory page

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Move With Air: Exercise Training Study

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