Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07454395
Eligibility Criteria:
Inclusion Criteria For ME/CFS participants:
* Be between the ages of 18-80
* Meet the criteria of (ME/CFS). The diagnostic criteria for ME/CFS according to the primary Canadian Consensus Criteria are: 1. Fatigue (significant physical and mental fatigue that is new onset, unexplained, persistent or recurrent, and substantially reduces activity level), 2. Post-exertional malaise and/or post-exertional fatigue (general feeling of discomfort, weakness and/or fatigue, and potentially worsening associated symptoms, following physical or mental exertion; slow recovery which is usually longer than 24 hours), 3. Sleep dysfunction (unrefreshing sleep or disturbances in sleep quantity or rhythm), and 4. Pain (significant degree of muscle and/or joint pain, and/or significant headaches of new type, pattern or severity). This may include individuals with (but not limited to) Post-Viral Fatigue Syndrome, Long-Covid 19, Overtraining Syndrome (OTS), and/or co-occurring Postural Orthostatic Tachycardia Syndrome (POTS), Fibromyalgia, and/or Mast Cell Activation Syndrome (MCAS).
* Experience some degree of post exertional malaise and have some degree of exercise intolerance upon physical exertion.
* Must have been previously physically active and be able to swim
* Must be considered moderate-to-mild CFS (not severe or very severe) with a FUNCAP27 score between 3.0-5.8.
* Must be able to do some light physical activity and go to public places without causing post-exertional malaise.
Exclusion Criteria for all participants:
* Individuals with cardiovascular, pulmonary, metabolic, renal, endocrine, autoimmune, neurological, inflammatory condition, infectious disease, or mental illness that makes exercise participation a risk will be excluded from the study.
* Individuals who are pregnant will be excluded from the study.
* Individuals with musculoskeletal injuries that prevent exercise participation will be excluded from the study
Inclusion Criteria for healthy controls:
* Be between the ages of 18-80
* Must be physically active and be able to swim.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07454395
Study Brief:
Protocol Section:
NCT07454395