Move With Air: Can a Fan Maximize the Benefits of a Supervised Exercise-training Program in Adults With Cardiopulmonary Disease?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Cardiopulmonary exercise testing endurance time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Cardiopulmonary exercise testing endurance time
时间窗: Pre- and post-5 week of exercise training period.
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).
Borg modified 0-10 category ratio scale for breathlessness intensity
时间窗: Pre- and post-5 week of exercise training period.
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.
次要结局
- Minimal clinically important difference breathlessness intensity(Pre- and post-5 week of exercise training period.)
- Cardiopulmonary exercise test physiological response (power output)(Pre- and post-5 week of exercise training period.)
- COPD Assessment Test(Pre- and post-5 week of exercise training period.)
- Baseline Dyspnea Index and Transition Dyspnea Index(Pre- and post-5 week of exercise training period.)
- Modified Medical Research Council Dyspnea Scale (mMRC)(Pre- and post-5 week of exercise training period.)
- Dual-Energy X-Ray Absorptiometry-derived body composition(Pre- and post-5 week of exercise training period.)
- Cardiopulmonary exercise test physiological response (gas exchange)(Pre- and post-5 week of exercise training period.)
- Minimal clinically important difference exercise endurance(Pre- and post-5 week of exercise training period.)
研究者
Dennis Jensen, Ph.D.
Associate Professor
McGill University