NCT05478018

Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients

Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

55 patients with SLE have been included and randomized in a 1:1 fashion to a 12 week high intensity interval training (HIIT) course or standard care. Randomization was stratified by sex. All patients will undergo baseline and followup testing including: VO2Max, Pulmonary Function, Capillaroscopy, OGTT, Blood Tests, Epigenetic Markers of IFN, TNF and IL-6 signalling, Echocardiography,DXA, Medical Examination, Acute Exercise Bout with blood tests during and after an exercise bout similar to the intervention. A subgroup of patients will be offered a 82-Rb Pet CT of the heart as opt-in. The exercise programme consists of 12 weeks of tri-weekly exercise bouts of 38-45 minutes, following warm-up subjects will undergo 4 sets of 4 minute high intensity exercise, measured as the pulse being above 85% of HRmax for more than half the time; and 3 minute low to medium intensity exercise between the high intensity sets, measured as the pulse being between 40 to 60% of HRmax.

Conditions

• Systemic Lupus Erythematosus
• Interferon Deficiency

Interventions

Type	Name	Description
BEHAVIORAL	High Intensity Interval Training (HIIT)	Supervised high-intensity interval training for 12 weeks three times per week

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-04-16
• Completion: 2025-01-01
• First posted: 2022-07-28
• Last updated: 2025-09-09

Locations

1 site across 1 country: Denmark