Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors

NCT05196529 | Completed

• 1 other identifier: SOLVE ME/CFS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Myalgic Encephalomyelitis; Post-acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (4)

• Chemoreflex function

  Ventilatory responses to the administration of 10% hypoxia or 5% hypercapnia will be measured.

  8 weeks

• Clinical autonomic function

  Cardiovascular responses to autonomic battery of tests

  8 weeks

• Vascular function

  Brachial artery dilation response to 5 minutes of circulatory occlusion (flow-mediated dilation).

  8 weeks

• Cognitive function

  Performance on proprietary cognitive function software

  8 weeks

Secondary Outcomes (2)

• Cardiorespiratory fitness

  8 weeks

• ME symptoms

  8 weeks

Study Arms (1)

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.

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training OTHER

All participants will undergo inspiratory muscle training.

Inspiratory muscle training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• York University: lead

Study Sites (1)

York University

Toronto, Ontario, M3J1P3, Canada

Location

Related Publications (1)

• Edgell 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.

  PMID: 39374820 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders

Study Officials

• Heather Edgell, PhD

  York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 19, 2022
• Study Start: May 9, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)