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 @ 4:37 AM
Ignite Modification Date:
2025-12-25 @ 4:37 AM
NCT ID:
NCT05478018
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years by inclusion.
* Able to provide informed consent.
* Diagnosed SLE and fulfilling the classification criteria for SLE based on the American College of Rheumatology/EULAR criteria (SLICC)
Exclusion Criteria:
* Health conditions that prevent participating in the exercise intervention determined by the Research Coordinator these include but are not limited to
* Major bone fracture at inclusion
* Significant myalgias exacerbated by physical exercise
* Active infectious disease such as Covid-19
* Severe symptomatic pleuritis or pericarditis
* Corticosteroid use \> 10mg/day at baseline
* Diagnosed with diabetes mellitus by physician
* Pregnancy
* SLEDAI-2k (with the SELENA modifications to Proteinuria changes so as to not exclude patients with chronic proteinuria) \> 10
* Contraindications to 82Rb-PET with adenosine stress (according to local guidelines at the Dept. of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, which are in accordance with the recommendations of the European Association of Nuclear Medicine)
* Fever, myocarditis or endocarditis
* Previous heart transplantation
* Dysregulated atrial or ventricular tachyarrhythmias
* Severe chronic obstructive pulmonary disease with a FEV1 of less than 50% of predicted
* Second or third degree sinoatrial or atrioventricular block
* Active bronchospasm at the time of the scan
* Systolic blood pressure \<90 or \>200 mmHg at the time of the scan
* Treatment with theophyllin within 7 days of the scan
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05478018
Study Brief:
Protocol Section:
NCT05478018