Move With Air: Exercise Training Study

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-03-30

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 following a 5-week exercise training period.

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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 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.

Conditions

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Chronic Obstructive Pulmonary Disease Interstitial Lung Disease Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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. They will also be kept relatively unaware of the study hypothesis.

Study Groups

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Exercise training with Fan-to-face

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 airflow speed will be chosen by each participant so that it is most comfortable to them. An anemometer will measure the airflow from the fan.

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.

Exercise training with no fan

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

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Fan

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)
* 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).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No