An Observational Study to Understand the Fitness, Body Composition, Physical Activity and Sleep Patterns in People With Cystic Fibrosis on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy Compared to Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Maximal oxygen uptake
研究概览
简要总结
Cystic fibrosis (CF) is the most common inherited condition in the United Kingdom, affecting approximately 10,837 people. It is well recognised that regular exercise is clinically important for people with CF. Exercise function measured by the maximal oxygen consumption during a cardiopulmonary exercise test is often reduced in people with CF and this has been attributed to multiple factors including, altered heart and blood vessel function, muscle function, reduced physical activity levels and poorer sleep quality.
New medicine (modulators) have become available for many people with CF. Modulators appear able to reduce sweat chloride concentrations, improve lung function and reduce the frequency of pulmonary exacerbations in people with CF. Little evidence exists to show how they may have changed the fitness and underlying mechanisms responsible for this in people with CF.
This study aims to:
- determine the exercise function
- determine the blood vessel function
- determine body composition
- determine physical activity and sleep levels in people with CF on modulator therapy compared to a healthy controls group.
详细描述
CF is the most common inherited condition in the United Kingdom, affecting approximately 10,837 people. CF affects the movement of salt and water across the body which leads to a thick sticky build up of mucus causing problems in the lungs and digestive system. CF also causes problems in other parts of the body for example, the heart, the blood vessels and muscles. This can impact a person with CFs' ability to exercise which can have impact prognosis, quality of life and increase the amount of times someone with CF is admitted to hospital due to a chest infection.
For many people with CF, new medicine (modulators) have lately become accessible bringing big changes to their health. Elexacaftor-tezacaftor-ivacaftor (ETI) is the most recently approved modulator for use in people with specific CF transmembrane conductance regulator gene mutations and is now the most widely used modulator therapy. So far clinical trials have largely looked at lung function, sweat chloride levels and body mass index. The wider reaching effects of modulator therapy on exercise function has not been studied. This study will see if people with CF have blood vessel and exercise dysfunction, abnormal body composition and reduced physical activity and sleep quality when they are taking modulator therapy compared to a healthy group.
The aims of this study are:
- Determine the aerobic exercise function and mechanisms underlying this in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls;
- Determine the peripheral muscle function in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls;
- Determine the functional exercise capacity in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls;
- Determine the micro- and macrovascular endothelial function in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls;
- Determine body composition in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls;
- Determine the physical activity levels and sleep duration and quality in people with CF stable on ETI and whether this is different to healthy age- and sex-matched controls
This study will recruit 50 people with CF and 50 healthy age- and sex-matched control participants who are older than 10 years of age. It will ask them to attend the University of Portsmouth for 2 visits. The first visit will last ~3 hours. During this time they will undergo measures on blood vessel function and aerobic exercise function. The second visit will last ~2 hours. During this time they will undergo a body composition scan and a series of muscle function test. At home, participants will wear an accelerometer for 7 days and complete a series of questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Maximal oxygen uptake
时间窗: Day 1 - baseline
Between group differences in maximal oxygen uptake derived from a maximal cardiopulmonary exercise testing on a cycle ergometer
次要结局
- Total minutes of physical activity (light, moderate, moderate to vigorous physical activity)(Physical activity will be measured continuously for 7 days)
- Peak minute ventilation(Day 1 - baseline)
- Cardiac output(Day 1 - baseline)
- Quadricep fatigability index(Day 2 - baseline)
- Handgrip strength(Day 2 - baseline)
- Body composition (total fat-free mass and total fat mass)(Day 2 - baseline)
- Forced Vital Capacity (%predicted)(Day 1 - baseline)
- Heart rate(Day 1 - baseline)
- Sleep efficiency (time in bed + time asleep)(Sleep efficiency will be measured continuously for 7 days)
- Maximum quadricep strength(Day 2 - baseline)
- Cystic fibrosis questionnaire revised(Day 2 - baseline)
- Oxygen uptake at the gas exchange threshold(Day 1 - baseline)
- Peak power output(Day 1 - baseline)
- Stroke volume index(Day 1 - baseline)
- Insulin iontophoresis(Day 1 - baseline)
- Percentage change in brachial artery diameter taken from the Flow Mediated Dilation assessment(Day 1 - baseline)
- Time to exhaustion(Day 1 - baseline)
- Near-infrared spectroscopy derived deoxygenated [haemoglobin + myoglobin](Day 1 - baseline)
- Forced Expiratory Volume in the 1st second (% predicted)(Day 1 - baseline)
- Acetylcholine iontophoresis(Day 1 - baseline)
- Sit to stand repetitions per minute(Day 2 - baseline)
- The Pittsburgh Sleep Quality Index(Day 2 - baseline)
- Habitual activity estimation scale(Day 2 - baseline)
- Perceived exertion (breathing effort, chest tightness, throat narrowing, perceived exertion)(Day 1 - baseline)
研究者
Dr Zoe Saynor
Reader (Associate Professor) in Clinical Exercise Physiology
University of Portsmouth