Disease-related Fatigue Monitoring Based on Body Signals Measured on the Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
研究概览
简要总结
This study investigates the use of physiological parameters as predictors of disease-related fatigue. For that purpose, wearable devices are used to monitor post-COVID-19 patients during their stay in a rehabilitation clinic. Besides, the effectiveness of respiratory training in reducing breathlessness and improving exercise breathing patterns in patients suffering from post-COVID-19 will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adults (≥18 years old)
- •suffering from post-COVID-19 fatigue (i.e., score equal or higher than 5 on the single-item fatigue [SIF] or the Fatigue Severity Scale [FSS])
- •admitted to Gais rehabilitation clinic
- •able to use a mobile phone
- •able to wear and handle the monitoring devices
排除标准
- •Patients suffering from a relevant comorbidity (i.e., comorbidity resulting in significant distortion of physiological signals [e.g., moderate to severe chronic obstructive pulmonary disease or persistent atrial fibrillation])
- •pregnancy
- •unable to use, wear or handle the monitoring systems
结局指标
主要结局
Quantification of fatigue based on self-reported fatigue by means of single item fatigue questionnaire
时间窗: after 12 weeks of rehabilitation
The single item fatigue (SIF) questionnaire is a multidimensional questionnaire developed for use in daily clinical practice. It has 5-items covering global fatigue, cognitive fatigue, emotional fatigue, physical fatigue, fatigue relief by sleep), each consisting of an 11-point likert scale (0 \[no fatigue\] to 10 \[severe fatigue\]), . Perceived fatigue was asked for the past 24 hours.
Tidal volume at anaerobic threshold
时间窗: after 12 weeks of rehabilitation
Tidal volume (in ml) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Physical activity intensity
时间窗: after 12 weeks of rehabilitation
The mean amplitude observed for the resultant acceleration (based on 3D acceleration measurements in g) is considered to be representative for the physical activity intensity. It will be obtained from acceleration measurements monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Heart rate
时间窗: after 12 weeks of rehabilitation
Heart rate (in beats per minute) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Heart rate variability
时间窗: after 12 weeks of rehabilitation
Heart rate variability (in milliseconds) will be obtained from ECG signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Breathing rate
时间窗: after 12 weeks of rehabilitation
Breathing rate (in breaths per minute) will be obtained from breathing waveform signals monitored continuously by the eqO2+ LifeMonitor (Equivital Inc, New York, USA)
Nocturnal blood oxygen saturation
时间窗: after 12 weeks of rehabilitation
Nocturnal blood oxygen saturation (in %) will be monitored continuously during night by Nonin Wristox2 3150 (Nonin Medical Inc., Minnesota, USA)
Breathing frequency at anaerobic threshold
时间窗: after 12 weeks of rehabilitation
Breathing frequency (in breaths per minute) obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
Respiratory exchange ratio at anaerobic threshold
时间窗: after 12 weeks of rehabilitation
Respiratory exchange ratio obtained during ergospirometer test using Cortex Metalyzer 3B (Cortex Biophysik GmbH, Leipzig, Germany) during a ramp protocol (starting work load of 5 Watts, increase in work load by 12.5 Watts/min).
次要结局
- Functional assessment by means of the hand grip test(after 12 weeks of rehabilitation)
- Functional assessment by means of the time up and go test(after 12 weeks of rehabilitation)
- Fatigue severity scale(after 12 weeks of rehabilitation)
- Functional assessment by means of the 6 min walking test(after 12 weeks of rehabilitation)
- Health-related quality of life assessment by means of short form health survey (SF-36)(after 12 weeks of rehabilitation)
- Chronic Respiratory Disease Questionnaire(after 12 weeks of rehabilitation)
- Edmonton Symptom Assessment System(after 12 weeks of rehabilitation)
- Hospital Anxiety and Depression Scale(after 12 weeks of rehabilitation)
- Bell Disability Scale(after 12 weeks of rehabilitation)
研究者
Simon Annaheim
Scientific Groupleader Materials-Body-Interaction Group
Empa, Swiss Federal Laboratories for Materials Science and Technology