Effects of Inspiratory Muscle 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
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Oxygen Consumption
研究概览
简要总结
Coronavirus-2019 (COVID-19) is a new virus that emerged in December 2019 and spread quickly all over the world. Problems such as hypoxia, dyspnea, increased fatigue, decreased exercise capacity and respiratory muscle strength occur in COVID-19 patients.In addition, abnormalities in skeletal muscles due to systemic inflammation, mechanical ventilation, sedation and prolonged bed rest in hospital and intensive care patients cause decreased exercise capacity.
详细描述
Dyspnea is one of the most common long-term symptoms in COVID-19 patients. It has been determined that dyspnea that persists three and six months after hospital discharge is associated with peak oxygen consumption in hospitalized and discharged COVID-19 patients, while peak oxygen consumption decreases in patients with dyspnea. Inspiratory muscle training may be an effective treatment modality in the treatment of dyspnea in patients with dyspnea after COVID-19. The effects of inspiratory muscle training have been investigated in different lung diseases. In these studies, inspiratory muscle training increased respiratory muscle strength and endurance, exercise capacity, and quality of life, and decreased fatigue and dyspnea.
The aim of this study is to investigate the effects of inspiratory muscle training on oxygen consumption, muscle oxygenation, physical activity level, respiratory muscle strength and endurance, peripheral muscle strength, functional exercise capacity, dyspnea, fatigue and quality of life in patients with COVID-19.
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 training group or 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
- •Between the ages of 18-75
- •Diagnosed with COVID-19
- •COVID-19 Polymerase Chain Reaction (PCR) test result negative
- •Volunteer to participate in the study
排除标准
- •Body mass index >35 kg/m2
- •Acute pulmonary exacerbation, acute upper or lower respiratory tract infection
- •Aortic stenosis, complex arrhythmia, aortic aneurysm
- •Serious neurological, neuromuscular, orthopedic, other systemic diseases or other diseases affecting physical functions
- •Cognitive impairment that causes difficulty in understanding and following exercise test instructions
- •Participated in a planned exercise program in the last three months
- •Bulla formation in the lung
- •Uncontrolled hypertension and/or diabetes mellitus, heart failure and cardiovascular disease
- •Contraindication for exercise testing and/or exercise training according to the American College of Sports Medicine
结局指标
主要结局
Oxygen Consumption
时间窗: First Day
Cardiopulmonary Exercises Test
次要结局
- Respiratory Muscle Endurance(Second day)
- Peripheral Muscle Strength(Second day)
- Muscle oxygenation(First and second day)
- Fatigue Severity(First day)
- Respiratory Muscle Strength(Second day)
- Functional exercise capacity(Second day)
- Dyspnea(First Time)
- Physical Activity Level(Second Day)
- Respiratory Associated Quality of Life (respiratory)(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