Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Study A) Heart Rate
研究概览
简要总结
Exercise testing has become clinically important in the management and ongoing evaluation of patients with Cystic Fibrosis (CF) with higher rates of exercise tolerance and participation previously linked to lower mortality risk (1).
Lower exercise capacity generally correlates with more severe lung disease (2,3) and landmark studies suggest that low exercise capacity as measured by peak oxygen capacity (VO2peak) and rate of decline in lung function (FEV1) are strong predictors of mortality (1,4). However not all studies have found pulmonary function tests (PFTs) to be reliable predictors of maximal exercise capacity (5), especially in relatively well preserved lung function (6,7).
The wide distribution in physical capacity between fit individuals and end stage disease adds to complexity of assessment. Independent factors of age, genetics, habitual exercise, nutritional status and musculoskeletal conditions are all known to influence physical capacity in patients with CF (8,9).
Maximal exercise testing places additional stress on cardiovascular, respiratory and peripheral systems providing more information around multiple influences on disease progression including degree of limitation in these major systems (10,11) and is useful for assessment of exercise desaturation, more common (but not always present) in advanced lung disease (5,12).
With prediction of exercise performance and functional capacity from PFTs unreliable and the understanding that health status correlates better with exercise tolerance there has been an increase in maximal exercise testing for patient management (13). Many international centers now regard exercise testing as highly important with many assessing maximal exercise capacity annually to monitor disease progression, identify physical status and drive changes in medical, physiotherapy or nutritional management (14,15).
The main vision is to develop a standardized incremental step test protocol suitable for adults with Cystic Fibrosis (CF), all ages, levels of fitness and disease state that is in line with current exercise testing recommendations (15). To develop a more useful field test to assess exercise tolerance and a more "user friendly" test than the currently available laboratory exercise test to allow for early detection of decline in physical function in the day-to-day clinical setting. To date no studies have been published in adults with CF where an incremental exercise step test has been investigated to assess exercise tolerance or determine maximum oxygen uptake (VO2max).
详细描述
Many international centers now regard exercise testing as highly important with many measuring maximal exercise capacity annually to monitor disease progression, identify physical status and to drive changes in medical, physiotherapy or nutritional management (14,15).
Cardiopulmonary Exercise Testing (CPET):
The current best practice for assessing VO2max in adults with CF is a CPET using the Godfrey Protocol, a progressive and incremental maximal test performed on a cycle ergometer (13,14,15). Exercise testing should aim to achieve a maximal response within a time frame of 8-12 min and incremental protocols with stage duration of 1 minute are considered more efficient in eliciting the desired response within this time frame (14). During CPET, VO2max is determined while breath-by-breath gas analysis allows for a comprehensive assessment of exercise ventilation and circulation. This information can identify reasons for low exercise capacity and whether exercise limitation is due to deconditioning, or primarily within the respiratory, cardiovascular or peripheral systems. CPET is performed using a specialist ergometer, and requires specialist clinical expertise, monitoring and reporting equipment for interpretation of the test. The cost, space and expertise to carry out CPET in CF units around the world may limit its use for the regular assessment of exercise capacity in adults with CF (16).
Field Tests:
Field tests generally cannot determine absolute maximal exercise capacity, but do provide valuable information about the patient's functional abilities and limitations and compared to laboratory tests are inexpensive and easy to administer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Diagnosis of CF (by genotype or positive sweat test)
- •Aged 18yrs and older
- •FEV1 ≥20% (Forced expiration in 1 sec)
- •Stable baseline state. (Stable baseline state is defined as: clinically stable respiratory status, for at least 30 days, characterized by the absence of hospitalization and no changes in maintenance therapy during this period (Yankaskas et al 2004)).
- •Haemoptysis
- •Uncontrolled asthma
- •Pneumothorax
- •Cardiac issues
- •Unreliable readings on pulse oximetry
- •Pulmonary hypertension
- •Unstable CF related diabetes (CFRD)
- •Vascular issues
- •Renal disease
- •Pregnancy
- •Body mass index (BMI) <18.0
- •Significant musculoskeletal issues
- •Unable to safely follow instructions
- •(ATS/ACCP 2003; Hebestreit 2015)
排除标准
- 未提供
结局指标
主要结局
Study A) Heart Rate
时间窗: Measures for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
Study B) Maximum oxygen uptake (VO2max)
时间窗: Measured during the incremental test for a maximum of 15 minutes.
The highest oxygen uptake achieved during the exercise test taken from inspired gas in a given period of time. Body weight is used to calculate this from oxygen consumption during the test. VO2peak may be used as a surrogate if VO2max is not achieved. Criteria for reaching maximum effort is not included in this document.
Study A) Oxygen Saturation
时间窗: Measured for 3 min prior to exercise (recorded at baseline sitting and standing), monitored during the test (recorded at minute intervals) and for at least 2 min of recovery up to a maximum of 10 minutes.
Standard objective outcome measures of field exercise testing. Measured via pulse oximetry.
次要结局
- Study B) Respiratory Exchange Ratio(Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.)
- Study B) Minute Ventilation(Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.)
- Study B) Oxygen Saturation(easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery)
- Study A & B) Duration of test; Highest level (mins and sec)/stage achieved; Reason for test termination.(Measured during or on completion of the test. Maximum 15 minutes.)
- Study B) Carbon Dioxide Production(Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.)
- Study B) Oxygen Pulse(Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.)
- Study B) Tidal Volume(Measured during the test incremental tests for a maximum 15 minutes and 5 mins of recovery.)
- Study B) Measures from Electrocardiogram(easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery)
- Study A & B) Breathlessness and Leg Fatigue(Measures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery)
- Study A & B) Blood pressure(Measures are takenpre/post A-STEP, pre/every 2 mins during/post CPET)
- Study B) Heart rate(easures are taken at baseline (post 5 mins), monitored during the test (recorded at minute intervals) and for min 5 mins of recovery)
研究者
Lisa Wilson
Senior Physiotherapist
The Alfred