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:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT03186794
Eligibility Criteria:
INCLUSION CRITERIA:
* Fulfilling 4 of the 11 American College of Rheumatology Criteria for the Classification of Systemic Lupus Erythematosus
* Age 21 to 80
* Female Gender
* BMI less than 40
* No primary or secondary medical conditions that would limit aerobic capacity or make exercise participation unsafe. (These conditions are found under the exclusion criteria listed below and include cardiovascular disease and cardiomyopathy, pulmonary and pulmonary vascular disease, stroke, significant hepatic or renal dysfunction, most cancers, diabetes mellitus, HIV infection, and peripheral vascular disease.)
* SELENA-SLEDAI score less than or equal to 4, maintained for at least three months. (C3 and C4 levels are measured as markers for stability and included in the SELENA-SLEDAI score if abnormal).
* No increase in doses of immunosuppressive medications (hydroxychloroquine, mycophenolate mofetil, azathioprine, methotrexate) for at least three months at the time of screening.
* No increase in the dose of prednisone or equivalent steroid in the past 3 months at the time of screening.
* Physically inactive, not participating in aerobic exercise training at heart rate above 60% maximum heart rate, 20 min/session or more, 2 or more days per week, within the last 6 months at the time of screening.
* Fatigue Severity Scale (FSS) composite score greater than or equal to 3 indicating the presence of clinically significant fatigue
* Subjects must be able to walk on a treadmill
EXCLUSION CRITERIA:
* Prednisone greater than or equal to 15 mg daily (or equivalent)
* Have started azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide or biologics within 3 months
* Rituximab infusion within 6 months
* Present symptoms of ischemic heart disease, right- or left-sided heart failure, cor pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or non- idiopathic cardiomyopathy
* Significant pulmonary dysfunction (obstructive, restrictive, or infectious pulmonary disease)
* Significant hepatic (LFT \> 2 times of upper limit of normal) or renal dysfunction (GFR\<45 ml/min)
* Deep vein thrombosis
* Chronic anticoagulation (with the exception of low dose aspirin) or a history of a bleeding disorder
* History or presence of any form of cancer other than skin cancer or cervical in-situ cancer
* History of cerebrovascular accident
* Orthopedic conditions that would limit performance of treadmill exercise tests or treadmill exercise training
* Current smoker or active substance abuse
* HIV infection
* Any medication that limit exercise capacity or the ability to adapt to aerobic exercise training (e.g. beta-blockers, anti-retroviral therapy for the treatment of HIV infection)
* Diabetes Mellitus
* Fibromyalgia: Determined at pre-screening visit, as per 2010 American College of Rheumatology (ACR) criteria for diagnosis of fibromyalgia
* Uncontrolled or untreated thyroid dysfunction: Determined by abnormal Thyroid Stimulating Hormone (TSH) level checked at the time of screening or within 3 months before screening visit.
* Currently pregnant, nursing or plan to become pregnant during the duration of the study
* Anemia (hemoglobin \< 9 g/dl)
* Significant peripheral vascular disease
* Severe Raynaud's phenomenon
* Individuals unable to give informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT03186794
Study Brief:
Protocol Section:
NCT03186794