Clinical trial NCT05646407: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Interstitial Lung Disease
Heart Failure
Keywords: Breathlessness
Dyspnea
Exercise
Fan-to-face therapy
Cool air
Exercise intolerance
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Cardiopulmonary exercise testing endurance time
timeFrame: Pre- and post-5 week of exercise training period.
measure: Borg modified 0-10 category ratio scale for breathlessness intensity
timeFrame: Pre- and post-5 week of exercise training period.
Secondary outcomes:
measure: Dual-Energy X-Ray Absorptiometry-derived body composition
timeFrame: Pre- and post-5 week of exercise training period.
measure: Cardiopulmonary exercise test physiological response (gas exchange)
timeFrame: Pre- and post-5 week of exercise training period.
measure: Cardiopulmonary exercise test physiological response (power output)
timeFrame: Pre- and post-5 week of exercise training period.
measure: Minimal clinically important difference breathlessness intensity
timeFrame: Pre- and post-5 week of exercise training period.
measure: Minimal clinically important difference exercise endurance
timeFrame: Pre- and post-5 week of exercise training period.
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Pre- and post-5 week of exercise training period.
measure: COPD Assessment Test
timeFrame: Pre- and post-5 week of exercise training period.
measure: Baseline Dyspnea Index and Transition Dyspnea Index
timeFrame: Pre- and post-5 week of exercise training period.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre of Innovative Medicine of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Dennis Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References: