Investigation of Oxygen Consumption Chronotropic Response and Physical Activity Level in Patients With Post COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Oxygen consumption
研究概览
简要总结
Pulmonary involvement and fibrosis could be seen in patients after COVID-19. Especially diffusion capacity, pulmonary function, exercise capacity and muscle strength have decreased in patients with COVID-19. Some symptom complaints of patients might continue after the disease, also. It has been shown that COVID-19 causes pulmonary involvement. However, the number of studies revealing the extent of pulmonary and extrapulmonary exposure due to COVID 19 comparing to healthy individuals is very limited, and has not been adequately investigated yet.
详细描述
Patients who had diagnosed with COVID-19 and participants who do not have any diagnosed disease will be evaluated in this study. Twenty-five patients with post COVID-19 and 25 age- and sex-matched healthy controls will be included according to inclusion and exclusion criteria. All assessments will be completed in two days. Oxygen consumption, physical activity level, chronotropic response, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional dyspnea, fatigue perception and quality of life will be investigated in patients with COVID-19 and compared with age- and sex-matched healthy controls.
Primary outcome measurements will be oxygen consumption (cardiopulmonary exercise test), chronotropic response (results of cardiopulmonary exercise test) and physical activity level (multi sensor activity device). Secondary outcome will be pulmonary function (spirometer), functional exercise capacity (six minute walk test), respiratory muscle strength (mouth pressure device), peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire) and functional status (Post-COVID-19 Functional Status Scale).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 18-75 years
- •diagnosed with COVID-19 before
- •patients whose COVID-19 Polymerase Chain Reaction test turned negative or be negative already
- •patients who are willing to participate in this study.
- •Healthy controls;
- •aged between 18-75 years
- •patients who are willing to participate in this study.
排除标准
- •body mass index >35 kg/m2
- •cancer, renal or hepatic diseases
- •aortic stenosis, complex arrhythmia, aortic aneurysm
- •serious neurological, neuromuscular, orthopedic, other systemic diseases or. other diseases affecting physical functions
- •uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
- •acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- •cognitive impairment that causes difficulty in understanding and following exercise test instructions
- •bulla formation in the lung
- •participated in a planned exercise program in the last three months
- •contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
- •Healthy controls;
- •history of coronavirus disease
- •history of smoke exposure below 10 packs*years
- •have any diagnosed chronic or systemic diseases
- •have psychiatric disorder
- •body mass index >35 kg/m2
- •cognitive impairment that causes difficulty in understanding and following exercise test instructions
- •acute pulmonary exacerbation, acute upper or lower respiratory tract infection
结局指标
主要结局
Oxygen consumption
时间窗: First day
Maximal exercise capacity will be assessed with symptom limited cardiopulmonary exercise test on a treadmill at a progressively increasing speed and grade. Oxygen consumption will be measured during the test.
Physical activity level
时间窗: Second day
Physical activity level will be evaluated with multi sensor activity device. Patients will be asked to wear the device for three consecutive days on weekdays.
Chronotropic response
时间窗: First day
The chronotropic response will be assessed using the results of the symptom limited cardiopulmonary exercise test. The chronotropic incompetence will be named according to the chronotropic index calculated from the test result.
次要结局
- Functional exercise capacity(Second day)
- Respiratory muscle strength(Second day)
- Peripheral muscle strength(Second day)
- Dyspnea(First day)
- Pulmonary function(Second day)
- Fatigue(First day)
- Life Quality(First day)
- Modified Borg Scale(During the exercise tests)
- Inspiratory muscle endurance(Second day)
- Functional status(First day)
研究者
Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Gazi University