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:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT00677157
Eligibility Criteria:
* INCLUSION CRITERIA:
To be included, patients must meet all of the following:
* Are greater than or equal to 18 years of age;
* Have symptoms of pain and/or fatigue.
EXCLUSION CRITERIA:
Patients with any one of the following will be excluded:
* Inability to provide informed consent for the study;
* Are unwilling or unable to cooperate with the study procedures or travel to NIH for the procedures.
In addition to the above criteria, participants with the following conditions will be excluded from the participating in the peak exercise testing:
* Pregnant or lactating women.
* Unable to refrain from smoking at least 4 hours prior to exercise testing sessions.
* Any medical condition that limits exercise performance and/or affects participants safety during exercise. This includes diseases of the cardiovascular, pulmonary, neurological, metabolic or musculoskeletal systems such as:
* Diagnosis or history of ischemic heart disease
* Dilated or hypertrophic cardiomyopathy
* Non-idiopathic cardiomyopathy
* Uncontrolled hypertension, defined as a resting blood pressure above 140/90 mmHg
* Diagnosis or history of right or left-sided heart failure or pulmonary hypertension
* Diagnosis or history of restrictive or obstructive lung disease
* Diagnosis or history of stroke
* Uncontrolled Type I or Type II Diabetes Mellitus
* Diagnosis of chronic liver disease, chronic kidney disease, acute kidney injury or acute liver failure
* Metastatic cancer active within the previous five years
* Mitochondrial disease
* On medications that would influence aerobic capacity or treadmill performance such as beta-blockers or antiretroviral therapy
* Active substance abuse including ETOH
* Medical or psychological instability such that subjects could not reasonably be expected to fulfill the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00677157
Study Brief:
Protocol Section:
NCT00677157