Move With Air: Exercise Training Study

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646407
• Other study ID #: FanEx 2023-9286
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: McGill University
• Contact: Rachelle I Aucoin, PhD Student
• Phone: 514-398-4184
• Email: rachelle.aucoin[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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
• 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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Honeywell HT-900 Turbo Force Air Circulator
This is a basic, portable, household fan with a single cost of CDN$21.99.

Locations

Country	Name	City	State
Canada	Centre of Innovative Medicine of the McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Pre- and post-5 week of exercise training period.
Secondary	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	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.
Secondary	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.	Pre- and post-5 week of exercise training period.

External Links

•   Link to Dr. Dennis Jensen's Clinical Exercise and Respiratory Physiology Laboratory page