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Spots Global Cancer Trial Database for Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients

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Trial Identification

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

Official Title: Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus

Study ID: NCT05478018

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Center for Physical Activity Research, Copenhagen, , Denmark

Contact Details

Name: Ronan Martin G Berg, MD, DMSc

Affiliation: Center for Physical Activity Research

Role: STUDY_CHAIR

Name: Iben E Rasmussen, MSc

Affiliation: Center for Physical Activity Research

Role: STUDY_CHAIR

Name: Simon Jønck, MD

Affiliation: Center for Physical Activity Research

Role: STUDY_CHAIR

Name: Malte L Adamsen, MD

Affiliation: Center for Physical Activity Research

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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