Inspiratory Muscle Training in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and COVID-19 Survivors
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
- Cognitive function
研究概览
简要总结
Coronavirus-2019 (COVID-19) is a viral disease leading to respiratory dysfunction, but it may also affect the brain and result in the development of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This may be the result of the COVID-19 virus infecting regions of the brain responsible for respiratory control. The symptoms of COVID-19 long haulers and ME/CFS may be lessened via an 8-week inspiratory muscle training protocol which is a simple and easy training protocol which can be done at a patient's home.
Thus, this project will investigate changes in the breathing and cardiovascular responses to stimuli in three groups of participants: 1) healthy control individuals; 2) patients diagnosed with ME/CFS (mild to moderate symptoms); and 3) individuals with previous COVID-19 infection with long-haul symptoms lasting for at least 3 months. Participants will 1) breathe hypoxic gas (10% O2) for 5 minutes; 2) breath hypercapnic gas (5% CO2) for 5 minutes; 3) breathe at a rate of 6 breaths per minute for a total of 8 breaths (paced deep breathing); and 4) complete 10 minutes upright tilt (70 degrees head up on a tilt-table). Patients will also complete 2 questionnaires concerning their symptoms and a 15 minute cognitive function test on a lab laptop. This will allow for the assessment of the brain's control over blood pressure and breathing. Participants will also complete a 6-minute walking exercise test at their own speed as a measure of their aerobic fitness. We hypothesize that COVID-19 survivors will have a worse cardiovascular and autonomic response and lower fitness, similar to ME/CFS patients, compared to healthy participants.Further, this will be improved after 8-weeks of inspiratory muscle training. These results may help clinicians recognize ME/CFS symptoms in patients recovering from COVID-19.
详细描述
Approximately 10 women and 10 men between the ages of 18-65 will be tested in each of 3 groups:
- Control participants will be free of previously diagnosed cardiovascular, metabolic, autonomic, or respiratory disease.
- COVID-19 participants will have both an official diagnosis and an official clearance of COVID-19. Patients will have long-haul symptoms for at least 3 months. Patients will be recruited via media, social media and clinical collaborators.
- ME/CFS participants will be recruited via media, social media and clinical collaborators. Only those with mild to moderate symptoms who can complete a 6 minute walk test will be recruited.
Prospective participants will be patients of the University Health Network (UHN) or Women's College Hospital, community members, friends, family, and co-workers of laboratory staff and students. Patients will be recruited from clinical sites by poster recruitment at collaborative clinics.
Exclusion criteria are severe symptoms of chronic fatigue syndrome, inability to stand on a tilt table, inability to walk for 6 minutes, previous cardiorespiratory disease (except for COVID-19 long-hauler symptoms and chronic fatigue syndrome itself), and inability to understand and read English.
Participants will be recruited via established clinical collaborators, from York University's student and staff population, previously known relationships with the research staff, poster recruitment, and advertisements on social media sites (e.g. York U reddit, Facebook, Instagram, LinkedIn and Twitter). Social media will not be used for conversations, only for advertisement purposes. Postings will include only the information that is included on the print poster. Recruitment at clinics will be done via posters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Control participants will be free of previously diagnosed cardiovascular, metabolic, autonomic, or respiratory disease.
- •COVID-19 participants will have both an official diagnosis and an official clearance of COVID-
- •Patients will have long-haul symptoms for at least 3 months. Patients will be recruited via media, social media and clinical collaborators.
- •ME/CFS participants will be recruited via media, social media and clinical collaborators. Only those with mild to moderate symptoms who can complete a 6 minute walk test will be recruited.
排除标准
- •severe symptoms of chronic fatigue syndrome
- •inability to stand on a tilt table
- •inability to walk for 6 minutes
- •previous cardiorespiratory disease (except for COVID long-hauler symptoms and chronic fatigue syndrome itself)
- •inability to understand and read English.
结局指标
主要结局
Cognitive function
时间窗: 8 weeks
Performance on proprietary cognitive function software
Vascular function
时间窗: 8 weeks
Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).
Clinical autonomic function
时间窗: 8 weeks
Cardiovascular responses to autonomic battery of tests
Chemoreflex function
时间窗: 8 weeks
Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.
次要结局
- ME symptoms(8 weeks)
- Cardiorespiratory fitness(8 weeks)
研究者
Heather Edgell
Associate Professor
York University