Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interferon Deficiency | — | UNRESOLVED | — |
| Systemic Lupus Erythematosus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Interval Training (HIIT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise
- description
- The patients will be randomized to 12-week supervised exercise training intervention or no exercise training. The exercise training program includes three supervised sessions per week over a 12-week period. The program consists of high intensity endurance training on ergometer bicycles. The intensity will progress throughout the 12 weeks of training. The training consists of 10 minutes of warm up at 40-60% maximum heart rate (HRmax), followed by 25 minutes of high intensity interval training (4 bouts of 4 min at \>85% HRmax interspaced by 3 minutes of low intensity training at 40-60% Hrmax) and finally a 3-10 min cool-down of 50% Hrmax
- interventionNames
- Behavioral: High Intensity Interval Training (HIIT)
- type
- NO_INTERVENTION
- label
- Non-Exercise
- description
- Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines.
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAdamsen ML, Rasmussen IE, Printz Lyngbaek MP, Louise L Petersen M, Jonck S, Siddiqi KZ, Forman JL, Egeberg CS, Lytzen AA, Hasbak P, Ellingsgaard H, Diederichsen LP, Berg RMG, Pedersen BK, Christensen RH, Hojgaard P, Jacobsen S. Randomized controlled single-center clinical trial of high-intensity interval training in patients with systemic lupus erythematosus. J Autoimmun. 2026 Aug;162:103595. doi: 10.1016/j.jaut.2026.103595. Epub 2026 Jul 8. PMID 42419149