Post-acute COVID-19 Syndrome Clinical Trial
— Inspire MEOfficial title:
Inspiratory Muscle Training in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and COVID-19 Survivors
Verified date | April 2023 |
Source | York University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | York University | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
York University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chemoreflex function | Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured. | 8 weeks | |
Primary | Clinical autonomic function | Cardiovascular responses to autonomic battery of tests | 8 weeks | |
Primary | Vascular function | Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation). | 8 weeks | |
Primary | Cognitive function | Performance on proprietary cognitive function software | 8 weeks | |
Secondary | Cardiorespiratory fitness | 6-minute walk distance | 8 weeks | |
Secondary | ME symptoms | DePaul symptom questionnaire | 8 weeks |