An interventional study of Inspiratory muscle training in Myalgic Encephalomyelitis and Post-acute COVID-19 Syndrome, sponsored by York University. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by York University · Not applicable, Interventional, and Basic science
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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.
Approximately 10 women and 10 men between the ages of 18-65 will be tested in each of 3 groups:
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.
Participants will fill out clinical questionnaires (COMPASS31 and DePaul Symptom Questionnaire) and complete a cognitive function test using BrDI software developed by Dr. Lauren Sergio. This software program is located on a lab laptop and consists of trials whereby participants move a mouse on a screen in particular directions as instructed. They will then complete the following in random order: 1) breathe hypoxic gas (10% O2) for 5 minutes; 2) breathe hypercapnic gas (5% CO2) for 5 minutes; 3) breathe at a rate of 6 breaths per minute (paced deep breathing); and 4) 10 minutes upright tilt (70 degrees on a tilt-table). Each trial will be separated by 10 minutes of supine rest. Participants will also complete a voluntary walking test whereby the distance walked in 6 minutes will be measured as an index of aerobic fitness. All of these trials will be conducted in 336 Calumet College and will be conducted both before and after the 8-weeks of inspiratory muscle training described below (i.e. at both their first and second visits).
All participants will be equipped to measure heart rate, beat-to-beat blood pressure, brain blood flow, ventilation and end-tidal gases. Heart rate (HR) will be measured by electrocardiogram (ECG), and blood pressure will be monitored using a beat-by-beat non-invasive blood pressure device on the middle finger (NexFin). Brain blood flow velocity from the middle cerebral artery in the brain will be recorded using ultrasound and a 2MHz probe (Multigon Industries Inc.) positioned on the temple and held in place by an adjustable head-band. Respiratory outcomes such as ventilation, tidal volume, breathing frequency, exhaled gases will be measured through a mouthpiece that will be attached to a pneumotachometer (a nose plug will be worn).
These experiments will take approximately 2.5 hours per testing session.
Using commercially available devices, the 8-week inspiratory muscle training protocol consists of using 80% of maximal inspiratory pressure (determined in lab), 3x per week, 6 sets of 6 repetitions. Each set will be separated by decreasing lengths of time over the 8 weeks starting at a 30 second interim. This totals 36 inhalations 3 times per week. Progress will be determined via weekly phone calls with the participants and progress will also be logged by participants over the 8 weeks
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →York University is the lead sponsor of 51 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
The 8-week inspiratory muscle training protocol consists of using 80% of maximal inspiratory pressure (determined in lab), 3x per week, 6 sets of 6 repetitions. Each set will be separated by decreasing lengths of time over the 8 weeks starting at a 30 second interim. This totals 36 inhalations 3 times per week. Progress will be determined via weekly phone calls with the participants and progress will also be logged by participants over the 8 weeks.
Other: Inspiratory muscle training
All participants will undergo inspiratory muscle training.
Chemoreflex function
Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.
Time frame: 8 weeks
Clinical autonomic function
Cardiovascular responses to autonomic battery of tests
Time frame: 8 weeks
Vascular function
Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).
Time frame: 8 weeks
Cognitive function
Performance on proprietary cognitive function software
Time frame: 8 weeks
Cardiorespiratory fitness
6-minute walk distance
Time frame: 8 weeks
ME symptoms
DePaul symptom questionnaire
Time frame: 8 weeks
Plan to share: No — No individual data will be shared with anyone unless legally required to do so.
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in Jan 2023, 8 months.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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