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Inspiratory muscle training for Chronic Fatigue Syndrome (Inspire ME Trial)

N/A
Waitlist Available
Led By Heather Edgell, PhD
Research Sponsored by York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Inspire ME Trial Summary

This trial 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 1 year.

Eligible Conditions
  • Chronic Fatigue Syndrome (CFS)
  • Post-COVID Syndrome

Inspire ME Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chemoreflex function
Clinical autonomic function
Cognitive function
+1 more
Secondary outcome measures
Cardiorespiratory fitness
ME symptoms

Inspire ME Trial Design

1Treatment groups
Experimental Treatment
Group I: Inspiratory muscle trainingExperimental Treatment1 Intervention
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.

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Who is running the clinical trial?

York UniversityLead Sponsor
58 Previous Clinical Trials
17,436 Total Patients Enrolled
Heather Edgell, PhDPrincipal InvestigatorYork University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental protocol cater to seniors aged 85 and over?

"According to the eligibility criteria, individuals aged 18-65 are qualified for this trial; however, there is a greater abundance of trials available for those younger than 18 (515) and older than 65 (1884)."

Answered by AI

What criteria must be met in order to qualify for this research project?

"This study is searching for 60 volunteers aged between 18 and 65 with Chronic fatigue syndrome. To be eligible, control participants must not have a history of cardiovascular, metabolic, autonomic or respiratory disease; COVID-19 patients must have an official diagnosis as well as clearance from the virus; ME/CFS candidates must demonstrate mild to moderate symptoms that enable them to complete a 6 minute walk test. Potential patients will be sourced through media outlets, social networks and clinical partners."

Answered by AI

Is this research project currently recruiting participants?

"According to the details supplied on clinicaltrials.gov, recruitment for this trial is currently in progress. This medical research was first made available on May 9th 2022 and its most recent update happened on September 22nd of the same year."

Answered by AI

How many individuals have volunteered to participate in this trial?

"Affirmative. According to the clinicaltrials.gov platform, this research study is still recruiting participants since its initial posting on May 9th 2022 and most recent update on September 22nd 2022. Sixty patients are required from one medical centre in order for the trial to be completed successfully."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
How old are they?
18 - 65
What site did they apply to?
York University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors
Heather Edgell 2022. "Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05196529.
~14 spots leftby Apr 2025
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