Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients (NCT05478018) | Clinical Trial Compass
CompletedNot Applicable
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients
Denmark55 participantsStarted 2022-04-01
Plain-language summary
Investigating the physiological effects of the interferons type 1 and 2 (IFNs), and the cytokines Interleukin 6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with systemic lupus erythematosus (SLE).
The investigators hypothesize that the pathogenic blockage of IL-6 signalling that occurs in SLE, will decrease the cardiac and metabolic adaptations to aerobic exercise, and this decrease can be related to the IFN signature.
55 patients was included in a 12-week investigator blinded 1:1 randomised high intensity aerobic exercise intervention study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Treatm…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.