NCT05478018Completed
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 21 Jul 2022
- Start date
- 1 Apr 2022
- Primary completion date
- 16 Apr 2024
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Lupus (SLE)
- NCT number
- NCT05478018
What you commit to
- Study type: Interventional
- Participants enrolled: 55
- From 1 Apr 2022 to the primary completion date, 16 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Corticosteroid use \> 10mg/day at baseline
- 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
Other illness
- 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
- Diagnosed with diabetes mellitus by physician
Other
- Pregnancy
- SLEDAI-2k (with the SELENA modifications to Proteinuria changes so as to not exclude patients with chronic proteinuria) \> 10
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Physical Activity Research Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
- Randomized controlled single-center clinical trial of high-intensity interval training in patients with systemic lupus erythematosus.J Autoimmun · 2026 · PMID 42419149
This page is information, not medical advice. Discuss any trial with your doctor.