Myalgic EncephalomyelitisInspire MENCT05196529
Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors
A study testing Inspiratory muscle training in people with Myalgic Encephalomyelitis and Post-acute COVID-19 Syndrome, run by York University at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myalgic Encephalomyelitis, Post-acute COVID-19 Syndrome
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Training in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and COVID-19 Survivors
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.
Read the detailed description
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.
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
- Being tested
- Inspiratory muscle training
- Medical subject headings
- Fatigue Syndrome, Chronic, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
All participants will undergo inspiratory muscle training.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | 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. Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemoreflex function
Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.
Measured: 8 weeks
Clinical autonomic function
Cardiovascular responses to autonomic battery of tests
Measured: 8 weeks
Vascular function
Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).
Measured: 8 weeks
Cognitive function
Performance on proprietary cognitive function software
Measured: 8 weeks
Secondary outcomes (2)
Cardiorespiratory fitness
6-minute walk distance
Measured: 8 weeks
ME symptoms
DePaul symptom questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start9 May 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myalgic EncephalomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Three groups (controls, ME/CFS, COVID long-haulers) will all conduct an inspiratory training protocol and cardiovascular and autonomic measures will be measured before and after.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Edgell, York University
- Investigators
- Heather Edgell, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196529
- Sponsor's protocol ID
- SOLVE ME/CFS
- Acronym
- Inspire ME
- Status last verified
- Apr 2023
- First submitted
- 13 Jan 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared with anyone unless legally required to do so.
Publications
Badhwar S, Pereira TJ, Kerr K, Bray R, Tabassum F, Sergio L, Edgell H. Autonomic phenotyping, brain blood flow control, and cognitive-motor-integration in Long COVID and myalgic encephalomyelitis/chronic fatigue syndrome: A pilot study. Auton Neurosci. 2025 Dec;262:103358. doi: 10.1016/j.autneu.2025.103358. Epub 2025 Oct 14.
PubMed 41138391Edgell H, Pereira TJ, Kerr K, Bray R, Tabassum F, Sergio L, Badhwar S. Inspiratory muscle training improves autonomic function in myalgic encephalomyelitis/chronic fatigue syndrome and post-acute sequelae of SARS-CoV-2: A pilot study. Respir Physiol Neurobiol. 2025 Jan;331:104360. doi: 10.1016/j.resp.2024.104360. Epub 2024 Oct 6.
PubMed 39374820
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and COVID-19 Survivors
- ClinicalTrials.gov ID
- NCT05196529
- Acronym / sponsor ID
- Inspire ME / SOLVE ME/CFS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Three groups (controls, ME/CFS, COVID long-haulers) will all conduct an inspiratory training protocol and cardiovascular and autonomic measures will be measured before and after.
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Other: Inspiratory muscle trainingThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingAll participants will undergo inspiratory muscle training. | Other | Inspiratory muscle training |
Primary outcome
Chemoreflex function
Time frame: 8 weeks
Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.
Clinical autonomic function
Time frame: 8 weeks
Cardiovascular responses to autonomic battery of tests
Vascular function
Time frame: 8 weeks
Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).
Cognitive function
Time frame: 8 weeks
Performance on proprietary cognitive function software
2 secondary outcomes
Cardiorespiratory fitness
Time frame: 8 weeks
ME symptoms
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 41138391Badhwar S, Pereira TJ, Kerr K, Bray R, Tabassum F, Sergio L, Edgell H. Autonomic phenotyping, brain blood flow control, and cognitive-motor-integration in Long COVID and myalgic encephalomyelitis/chronic fatigue syndrome: A pilot study. Auton Neurosci. 2025 Dec;262:103358. doi: 10.1016/j.autneu.2025.103358. Epub 2025 Oct 14.
- Derived from this study: PubMed 39374820Edgell H, Pereira TJ, Kerr K, Bray R, Tabassum F, Sergio L, Badhwar S. Inspiratory muscle training improves autonomic function in myalgic encephalomyelitis/chronic fatigue syndrome and post-acute sequelae of SARS-CoV-2: A pilot study. Respir Physiol Neurobiol. 2025 Jan;331:104360. doi: 10.1016/j.resp.2024.104360. Epub 2024 Oct 6.
- Individual participant dataSharing planned: No. No individual data will be shared with anyone unless legally required to do so.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Edgell, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Myalgic Encephalomyelitis and Post-acute COVID-19 Syndrome, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemoreflex function (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196529, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.