The Effect of Home-based Breathing and Chest Mobilisation Exercise on Cardiorespiratory Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Change of 6-minutes walking test
研究概览
简要总结
Objective propose: to investigate the effect of home based breathing exercise and chest mobilization on the cardiorespiratory functional capacity of Covid-19 survivors with cardiovascular comorbidity.
Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. It is hypothesized that breathing exercise and chest mobilization in Covid-19 survivors will give benefits to Covid-19 survivors with cardiovascular disease.
详细描述
Lung restrictive disorder is one of the reasons that induce chronic fatigue in COVID-19 (Corona Virus Disease-19) survivors. It also gives a significant effect on cardiovascular patients who are in the second phase of cardiac rehabilitation. Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. On the other hand, there is still no research that shows the effectiveness of Breathing exercises and chest mobilization in Covid-19 survivors who are suffering from cardiovascular problems.
Patients in National Cardiac Center Hospital, Jakarta, with a history of Covid-19 and have cardiovascular disease are recruited. They will undergo pre and post-exercise examinations such as blood sampling, do 6 minutes walking test, Peak Cough Flow and Peak Flow Rate test, measuring the chest dimension, treadmill, and answer the European Quality of Life Five Dimension (EQ-5D) questions. With randomization, patients will be determined to treatment or control group. They will be prepared about what exercises should they do at home. Subjects will be supervised digitally and regularly through Zoom meetings. Exercises will be done for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease
- •Able to communicate and operate Youtube and Zoom.
排除标准
- •Limitation to move any part of the body that causes the inability to do the instructed exercise.
- •Feel pain in extremities (visual analog scale >3)
- •Chronic Obstructive Pulmonary Disease
- •Neuromuscular disorder (stroke, peripheral neuropathy with significant motoric control disturbance
- •Musculoskeletal disorder (fracture, post amputation, severe arthritis in support joints)
结局指标
主要结局
Change of 6-minutes walking test
时间窗: Change from Baseline 6-minutes walking test at 3 months
To define initial ability to walk in 30 minutes for second phase cardiac rehabilitation (aerobic exercise). Unit of measure : meter
Change of Cardiac Exercise Test
时间窗: Change from Baseline Cardiac Exercise Test at 3 months
Patients walk on treadmill. Unit of measure : minutes, METs (Metabolic Equivalent of Task)
Change of Peak Cough Flow (PC)
时间窗: Change from Baseline Peak Cough Flow (PC) at 3 months
to define the functional capacity. Unit of measure : L/min.
Change of Peak Flow Rate (PFR)
时间窗: Change from Baseline Peak Flow Rate (PFR) at 3 months
to define the functional capacity. Unit of measure : L/min.
次要结局
- Change of Lymphocyte(Change from Baseline Lymphocyte at 3 months)
- Change of C-Reactive Protein(Change from Baseline C-Reactive Protein at 3 months)
- Change of Mean Corpuscular Hemoglobin(Change from Baseline Mean Corpuscular Hemoglobin at 3 months)
- Change of Neutrophil(Change from Baseline Neutrophil at 3 months)
- Change of Hematocrit(Change from Baseline Hematocrit at 3 months)
- Change of Mean Corpuscular Volume(Change from Baseline Mean Corpuscular Volume at 3 months)
- Change of Platelet(Change from Baseline Platelet at 3 months)
- Change of Hemoglobin(Change from Baseline Hemoglobin at 3 months)
- Change of Erythrocyte(Change from Baseline Erythrocyte at 3 months)
- Change of European Quality of Life Five Dimension (EQ-5D)(Change from Baseline EQ-5D at 3 months)
- Change of Eosinophil(Change from Baseline Eosinophil at 3 months)
- Change of Monocyte(Change from Baseline Monocyte at 3 months)
- Change of Mean Corpuscular Hemoglobin Concentration(Change from Baseline Mean Corpuscular Hemoglobin Concentration at 3 months)
- Change of Red Cell Distribution Width(Change from Baseline Red Cell Distribution Width at 3 months)
- Change of Leucocyte(Change from Baseline Leucocyte at 3 months)
- Change of D-dimer(Change from Baseline D-dimer at 3 months)
- Change of Basophil(Change from Baseline Basophil at 3 months)
研究者
Bambang Dwiputra, MD
MD Cardiologist, Principal Investigator
National Cardiovascular Center Harapan Kita Hospital Indonesia