Effects of High-Intensity Interval Aerobic Exercise Training on Oxygen Consumption Muscle Oxygenation and Physical Activity Level in Patients With Post COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Oxygen consumption
研究概览
简要总结
Many structures and organs are adversely affected after COVID-19. The most obvious and common problem is lung involvement. In the pathology report of the patients, it has been shown that there are changes such as diffuse alveolar damage, bronchiolitis and interstitial fibrosis. The most prominent effect of COVID-19 in patients with reduced lung functions is reduced diffusion capacity. While the disease severity worsens, pulmonary fibrosis becomes more pronounced in cases. The complaints of dyspnea and fatigue of patients after discharged continue. Inspiratory and expiratory respiratory muscle weakness are observed in more than 50% of patients with COVID-19, measured in the first month after the discharged. This respiratory muscle weakness is associated with myopathy due to hypoxemia, oxygen support, prolonged bed rest and corticosteroid use, regardless of disease severity.
It is seen that these patients with COVID-19 need exercise training because of lung involvement, decreased exercise capacity and persistence of some symptom complaints after the discharged.
详细描述
Patients with COVID-19 have not only reduced respiratory capacity, but also diminished muscle strength, exercise capacity, weakness cardiac system. In parallel with aforementioned, physical activity level and quality of life get worse in this patients. Therefore, the patients with COVID-19 need exercise training after the discharged. In the literature, the achievement of exercise training in many aspects such as exercise capacity, lung health, respiratory muscle strength, dyspnea has been proven in many diseases such as chronic obstructive pulmonary disease and heart failure.
Effects of high-intensity interval aerobic exercise training on oxygen consumption, muscle oxygenation, physical activity level, pulmonary function, functional exercise capacity, respiratory and peripheral strength, inspiratory muscle endurance, functional status, dyspnea, fatigue perception and quality of life have not been investigated in literature in patients with COVID-19. According to inclusion and exclusion criteria, 15 patients for training group and 15 patients for control group will be included. All assessments will be completed in two days before and after eight weeks training.
Primary outcome measurement will be oxygen consumption (cardiopulmonary exercise test).
Secondary outcome will be muscle oxygenation (Moxy device), physical activity level (multi sensor activity device), pulmonary function (spirometer), functional exercise capacity (six-minute walk test), respiratory (mouth pressure device) and peripheral muscle (hand-held dynamometer) strength, inspiratory muscle endurance (incremental threshold loading test), functional status (Post-COVID-19 Functional Status Scale), dyspnea (London Chest Daily Living Activity Scale), fatigue (Fatigue Severity Scale) and quality of life (Saint George Respiratory Questionnaire).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple-blind study; the patients will not be informed about their groups (training group or the control group) and they will be evaluated and trained at different places and times.
Evaluations and interventions will be performed different physiotherapist. In addition, before statistical analysis patients' groups will be coded.
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
- 否
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
排除标准
- •Patients with
- •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
研究组 & 干预措施
Training Group
Training group will receive high-intensity interval aerobic exercise training on treadmill accompanied by physiotherapist for 8 weeks.
干预措施: High-intensity interval aerobic exercise training (Other)
Control Group
Breathing exercises will be given to control group as a home program for 8 weeks.
干预措施: Control Group (Other)
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.
次要结局
- Pulmonary function(Second day)
- Respiratory muscle strength(Second day)
- Functional exercise capacity(Second day)
- Fatigue(First day)
- Borg Scale(During exercise training)
- Modified Borg Scale(During the exercise tests)
- Functional status(First day)
- Life Quality(Second day)
- Muscle Oxygenation(First and second day)
- Physical activity level(Second day)
- Peripheral muscle strength(Second day)
- Inspiratory muscle endurance(Second day)
- Dyspnea perception(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