Center for Physical Activity Research
Copenhagen, 2200, Denmark
NCT Number: NCT05478018
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2200, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supervised high-intensity interval training for 12 weeks three times per week
Other names: Aerobic Exercise
Time frame: 12 weeks
Measured by VO2max test
Time frame: 12 weeks
measured by Fatigue Severity Scale Questionnaire (FSS)
Time frame: 12 weeks
Physician evaluated changes in measures of SLE on a scale of 0-105 encompassing symptoms from 9 organs, higher scores indicate increased disease activity.
Time frame: 12 weeks
Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status
Time frame: 12 weeks
Measured by mRNA analysis
Time frame: 12 weeks
Itemized Physician evaluated changes in measures of SLEDAI-2K on a scale from 0-22 that account for partial improvements in condition, higher scores indicate increased disease activity.
Time frame: 12 weeks
Physician evaluated changes in measures of SLE (0-100% of line segment), higher scores equal higher disease activity (worse)
Time frame: 12 weeks
Patient reported outcome measures (PROMs) , higher scores equal higher fatigue (worse)
Time frame: 12 weeks
Patient reported outcome measures (PROMs), higher scores equal more pain (worse)
Time frame: 12 weeks
Patient reported outcome measures (PROMs), Possible scores range from 0 to 33, with higher scores representing more active SLE (worse)
Time frame: 12 weeks
Patient reported outcome measures (PROMs), Possible scores range from 1 to 10, with higher scores representing more active SLE
Time frame: 12 weeks
Measured by Dipstick in a semiquantitive manner with the following categories indicating increased concentration, negative, +/-, 1+, 2+, 3+, 4+.
Time frame: 12 weeks
Measured by DXA Scan - fat(g)
Time frame: 12 weeks
Measured by DXA Scan - fat(%)
Time frame: 12 weeks
Measured by DXA Scan - android fat(g)
Time frame: 12 weeks
Measured by DXA Scan - android fat(%)
Time frame: 12 weeks
Measured by DXA Scan - Gyneoid fat(g)
Time frame: 12 weeks
Measured by DXA Scan - Gyneoid fat(%)
Time frame: 12 weeks
Measured by DXA Scan - Muscle Mass(g)
Time frame: 12 weeks
Measured by DXA Scan - BMD(g/cm^2)
Time frame: 12 weeks
measured with tape measure
Time frame: 12 weeks
Pulmonary function testing, FEV1 volume
Time frame: 12 weeks
Pulmonary function testing, FEV1%
Time frame: 12 weeks
Pulmonary function testing, FVC Volume
Time frame: 12 weeks
Pulmonary function testing FVC%
Time frame: 12 weeks
Pulmonary function testing, FEV1/FVC ratio
Time frame: 12 weeks
Pulmonary function testing, FEV1/FVC ratio %
Time frame: 12 weeks
Pulmonary function testing, TLC Volume
Time frame: 12 weeks
Pulmonary function testing, TLC%
Time frame: 12 weeks
Pulmonary function testing, RV-Volume
Time frame: 12 weeks
Pulmonary function testing, RV%
Time frame: 12 weeks
Pulmonary function testing, AV-Volume
Time frame: 12 weeks
Pulmonary function testing, AV-%
Time frame: 12 weeks
Pulmonary function testing, DLCOc-Volume
Time frame: 12 weeks
Pulmonary function testing, DLCOc-%
Time frame: 12 weeks
Pulmonary function testing, KCO-Volume
Time frame: 12 weeks
Pulmonary function testing, KCO-%
Time frame: 12 weeks
75g of glucose taken while fasting
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician (score of 1-4, higher scores equal fewer capillaries)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Width Measured in µm
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Length Measured in µm
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Avascular Areas (1-4 higher scores indicate more avascular areas)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Capillary Disorganization (1-4 higher scores indicate more avascular areas)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Microhemorrhages (avg per finger)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Bushy Capillaries (average per millimeter)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Megacapillaries (average per millimeter)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Meandering capillaries (average per millimeter)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Tortous capillaries (average per millimeter)
Time frame: 12 weeks
Measured by Nailfold Capillaroscopy by trained physician - Physicians comment
Time frame: 12 weeks
blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time frame: 12 weeks
blood samples are collected and processed by a trained laboratory technician and analysed according to standard procedures.monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time frame: 12 weeks
measured by echocardiography
Time frame: 12 weeks
measured by echocardiography
Time frame: 12 weeks
measured by echocardiography
Time frame: 12 weeks
measured by echocardiography
Time frame: 12 weeks
measured by echocardiography
Time frame: 12 weeks
measured by echocardiography (& 82Rb-PET-CT)
Time frame: 12 weeks
Measured by 82Rb-Pet-CT, on a subset of 40 participants
Time frame: 12 weeks
Free-living physical activity is measured using axial accelerometer-based physical activity monitors (AX3; Axivity, Newcastle upon Tyne, UK) for a 3 to 5 day period
Time frame: 12 weeks
Analyzed for HS-CRP
Time frame: 12 weeks
Analyzed for Il-6
Time frame: 12 weeks
Analyzed for soluble Il-6-receptor
Time frame: 12 weeks
Analyzed for Il-1
Time frame: 12 weeks
Analyzed for Il-10
Time frame: 12 weeks
Analyzed for IFNα
Time frame: 12 weeks
Analyzed for IFNγ
Time frame: 12 weeks
Analyzed for hemoglobin
Time frame: 12 weeks
Analyzed for thrombocytes
Time frame: 12 weeks
Analyzed for sodium
Time frame: 12 weeks
Analyzed for potassium
Time frame: 12 weeks
Analyzed for chloride
Time frame: 12 weeks
Analyzed for hematocrit.
Time frame: 12 weeks
Analyzed for ferritin
Time frame: 12 weeks
Analyzed for Leukocyte Differential
Time frame: 12 weeks
Measured by mRNA analysis on PBMCs
Time frame: 12 weeks
Measured by mRNA analysis
Time frame: 12 weeks
Measured by mRNA analysis
Time frame: 12 weeks
Measured by mRNA analysis on PBMCs
Time frame: 12 weeks
Patient Reported by dietary diary
Time frame: 12 weeks
Patient Reported by dietary diary
Time frame: 12 weeks
Patient Reported by dietary diary
Time frame: 12 weeks
Patient Reported by dietary diary
Time frame: 12 weeks
Patient Reported by dietary diary
Time frame: 12 weeks
Optional for Participants: mRNA expression of genes related to TNF, IL-6, IFN alpha, beta and Gamma signalling
Time frame: 12 weeks
Optional for Participants: NF-κB p65 DNA binding activity (ELISA), phosphorylated and total JNK, phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).
Time frame: 12 weeks
Optional for Participants: NF-κB p65 DNA binding activity (ELISA) & NF-κB binding activity (Western blotting).
Time frame: 12 weeks
Optional for Participants: phosphorylated and total JNK,
Time frame: 12 weeks
Optional for Participants: phosphorylated AMPK (p-AMPK) total AMPK (Western blotting).
Time frame: 12 weeks
Resting heart rate measured by R-R intervals on 1-lead ECG
Time frame: 12 weeks
Rise from supine ratio of R-R intervals on 1-lead ECG
Time frame: 12 weeks
Expiration/Inspiration ratio of R-R intervals on 1-lead ECG
Time frame: 12 weeks
Valsalva Maneuver ratio of R-R intervals on 1-lead ECG
Rigshospitalet, Denmark
Other
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus
Acronym: LUPEX
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