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| Name | Class |
|---|---|
| Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise | Experimental | 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 |
|
| Non-Exercise | No Intervention | Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training (HIIT) | Behavioral | Supervised high-intensity interval training for 12 weeks three times per week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in maximal aerobic capacity (VO2max) | Measured by VO2max test | 12 weeks |
| Patient reported Fatigue | measured by Fatigue Severity Scale Questionnaire (FSS) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Y2K updated SLE disease activity (SLEDAI-2K) with the SELENA modifications | Physician evaluated changes in measures of SLE on a scale of 0-105 encompassing symptoms from 9 organs, higher scores indicate increased disease activity. | 12 weeks |
| Short Form (SF)-36 Health Survey (0-100) |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index-50 (SRI-50) | 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. | 12 weeks |
| Visual Analog Scale (VAS) of global disease by Physician (0-100%) |
Inclusion Criteria:
Exclusion Criteria:
Health conditions that prevent participating in the exercise intervention determined by the Research Coordinator these include but are not limited to
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)
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| Name | Affiliation | Role |
|---|---|---|
| Ronan Martin G Berg, MD, DMSc | Center for Physical Activity Research | Study Chair |
| Iben E Rasmussen, MSc | Center for Physical Activity Research | Study Chair |
| Simon Jønck, MD | Center for Physical Activity Research | Study Chair |
| Malte L Adamsen, MD | Center for Physical Activity Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Physical Activity Research | Copenhagen | 2200 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42419149 | Derived | Adamsen 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 Jul 8;162:103595. doi: 10.1016/j.jaut.2026.103595. Online ahead of print. |
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Data obtained through this study will be made publicly available 6 months after first publication. Academic researchers with interest in systemic lupus erythematosus or exercise therapy can contact the authors to get access before this embargo.
Data or samples shared will be coded, with no PHI included.
Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted immediate upon publication of the first paper, 6 months after article publication anonymized data will be made publicly accessible.
All data shared will be done in a fully anonymized way.
Access for the first 6 months following publication can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Following the first 6 months anonymized data will be publicly available.
For more information or to submit a request, please contact Malte.Lund.Adamsen.02@regionh.dk or Soeren.Jacobsen.01@regionh.dk
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 27, 2023 | Jun 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2024 | Jun 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status |
| 12 weeks |
| Change in Epigenetic Expression related to IFN alpha | Measured by mRNA analysis | 12 weeks |
Physician evaluated changes in measures of SLE (0-100% of line segment), higher scores equal higher disease activity (worse) |
| 12 weeks |
| Visual Analog Scale (VAS) fatigue (0-100) | Patient reported outcome measures (PROMs) , higher scores equal higher fatigue (worse) | 12 weeks |
| Visual Analog Scale (VAS) pain (0-100) | Patient reported outcome measures (PROMs), higher scores equal more pain (worse) | 12 weeks |
| SLAQ - (range 0 -33) | Patient reported outcome measures (PROMs), Possible scores range from 0 to 33, with higher scores representing more active SLE (worse) | 12 weeks |
| SLE activity Visual Analog Scale - (1-10) | Patient reported outcome measures (PROMs), Possible scores range from 1 to 10, with higher scores representing more active SLE | 12 weeks |
| Proteinuria | Measured by Dipstick in a semiquantitive manner with the following categories indicating increased concentration, negative, +/-, 1+, 2+, 3+, 4+. | 12 weeks |
| Body composition - Total adipose tissue - Weight | Measured by DXA Scan - fat(g) | 12 weeks |
| Body composition - Total adipose tissue - Percentage | Measured by DXA Scan - fat(%) | 12 weeks |
| Body composition - Android adipose tissue - Weight | Measured by DXA Scan - android fat(g) | 12 weeks |
| Body composition - Android adipose tissue - Percentage | Measured by DXA Scan - android fat(%) | 12 weeks |
| Body composition - Gyneoid adipose tissue - Weight | Measured by DXA Scan - Gyneoid fat(g) | 12 weeks |
| Body composition - Gyneoid adipose tissue - Percentage | Measured by DXA Scan - Gyneoid fat(%) | 12 weeks |
| Body composition - Total Lean Mass - Weight | Measured by DXA Scan - Muscle Mass(g) | 12 weeks |
| Body composition - Bone Mass Density - Weight/square-centimeter | Measured by DXA Scan - BMD(g/cm^2) | 12 weeks |
| Waist-To-Height Ratio | measured with tape measure | 12 weeks |
| Dynamic Spirometry - Forced Expiratory Volume at 1 second (FEV1) volume | Pulmonary function testing, FEV1 volume | 12 weeks |
| Dynamic Spirometry - Forced Expiratory Volume at 1 second (FEV1) Percent of expected | Pulmonary function testing, FEV1% | 12 weeks |
| Dynamic Spirometry - Forced Vital Capacity Volume | Pulmonary function testing, FVC Volume | 12 weeks |
| Dynamic Spirometry - Forced Vital Capacity - Percent of Expected | Pulmonary function testing FVC% | 12 weeks |
| Dynamic Spirometry Forced Expiratory Volume at 1 second (FEV1) by Forced Vital Capacity - Ratio | Pulmonary function testing, FEV1/FVC ratio | 12 weeks |
| Dynamic Spirometry Forced Expiratory Volume at 1 second (FEV1) by Forced Vital Capacity - Ratio - Percentage of expected | Pulmonary function testing, FEV1/FVC ratio % | 12 weeks |
| Dynamic Spirometry - Total Lung Capacity - Volume | Pulmonary function testing, TLC Volume | 12 weeks |
| Dynamic Spirometry - Total Lung Capacity - Percentage of expected | Pulmonary function testing, TLC% | 12 weeks |
| Dynamic Spirometry - Residual Volume - Volume | Pulmonary function testing, RV-Volume | 12 weeks |
| Dynamic Spirometry - Residual Volume - Percentage of Expected | Pulmonary function testing, RV% | 12 weeks |
| Dynamic Spirometry - Alveolar Volume - Volume | Pulmonary function testing, AV-Volume | 12 weeks |
| Dynamic Spirometry - Alveolar Volume - Percentage of expected | Pulmonary function testing, AV-% | 12 weeks |
| Dynamic Spirometry - Diffusing capacity for Carbon Monoxide - Volume | Pulmonary function testing, DLCOc-Volume | 12 weeks |
| Dynamic Spirometry - Diffusing capacity for Carbon Monoxide - Percentage | Pulmonary function testing, DLCOc-% | 12 weeks |
| Dynamic Spirometry - Carbon monoxide transfer coefficient - diffusing capacity per liter of lung volume | Pulmonary function testing, KCO-Volume | 12 weeks |
| Dynamic Spirometry - Carbon monoxide transfer coefficient - diffusing capacity per liter of lung volume - percentage of expected | Pulmonary function testing, KCO-% | 12 weeks |
| Oral glucose tolerance test | 75g of glucose taken while fasting | 12 weeks |
| Peripheral Capillary Changes - Capillary Density | Measured by Nailfold Capillaroscopy by trained physician (score of 1-4, higher scores equal fewer capillaries) | 12 weeks |
| Peripheral Capillary Changes - Average Capillary Width (micrometers) | Measured by Nailfold Capillaroscopy by trained physician - Width Measured in µm | 12 weeks |
| Peripheral Capillary Changes - Average Capillary Length(micrometers) | Measured by Nailfold Capillaroscopy by trained physician - Length Measured in µm | 12 weeks |
| Peripheral Capillary Changes - Count of avascular areas | Measured by Nailfold Capillaroscopy by trained physician - Avascular Areas (1-4 higher scores indicate more avascular areas) | 12 weeks |
| Peripheral Capillary Changes - Capillary Disorganization | Measured by Nailfold Capillaroscopy by trained physician - Capillary Disorganization (1-4 higher scores indicate more avascular areas) | 12 weeks |
| Peripheral Capillary Changes - Microhemorrhages (average per finger) | Measured by Nailfold Capillaroscopy by trained physician - Microhemorrhages (avg per finger) | 12 weeks |
| Peripheral Capillary Changes - Bushy Capillaries (average per millimeter) | Measured by Nailfold Capillaroscopy by trained physician - Bushy Capillaries (average per millimeter) | 12 weeks |
| Peripheral Capillary Changes - Megacapillaries (average per millimeter) | Measured by Nailfold Capillaroscopy by trained physician - Megacapillaries (average per millimeter) | 12 weeks |
| Peripheral Capillary Changes - Meandering capillaries (average per millimeter) | Measured by Nailfold Capillaroscopy by trained physician - Meandering capillaries (average per millimeter) | 12 weeks |
| Peripheral Capillary Changes - Tortous capillaries (average per millimeter) | Measured by Nailfold Capillaroscopy by trained physician - Tortous capillaries (average per millimeter) | 12 weeks |
| Peripheral Capillary Changes - Other Findings | Measured by Nailfold Capillaroscopy by trained physician - Physicians comment | 12 weeks |
| Change in fasting total cholesterol, low-density lipoprotein (LDL)-cholesterol and high-density lipoprotein (HDL)-cholesterol (mmol/L). Following an overnight fast (10 hours) | 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 | 12 weeks |
| Change in triglycerides (mmol/L). Following an overnight fast (10 hours) | 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 | 12 weeks |
| left ventricular and atrial end-diastolic volume | measured by echocardiography | 12 weeks |
| global longitudinal strain | measured by echocardiography | 12 weeks |
| stroke volume | measured by echocardiography | 12 weeks |
| left ventricular ejection fraction | measured by echocardiography | 12 weeks |
| Left ventricular mass | measured by echocardiography | 12 weeks |
| coronary perfusion reserve | measured by echocardiography (& 82Rb-PET-CT) | 12 weeks |
| Myocardial blood flow | Measured by 82Rb-Pet-CT, on a subset of 40 participants | 12 weeks |
| Axial accelerometer-based physical activity monitors | 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 | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for High Sensitvity C-Reactive Protein | Analyzed for HS-CRP | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-6 | Analyzed for Il-6 | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for sIL-6r | Analyzed for soluble Il-6-receptor | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-1 | Analyzed for Il-1 | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Il-10 | Analyzed for Il-10 | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for IFNα | Analyzed for IFNα | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for IFNγ | Analyzed for IFNγ | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for hgb | Analyzed for hemoglobin | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for plates | Analyzed for thrombocytes | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Na | Analyzed for sodium | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for K | Analyzed for potassium | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Cl | Analyzed for chloride | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for hct | Analyzed for hematocrit. | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for Ferritin | Analyzed for ferritin | 12 weeks |
| Change in peripheral blood Adaptation to Acute Exercise Bout - Analyzed for leucocyte differential | Analyzed for Leukocyte Differential | 12 weeks |
| Change in Epigenetic Expression related to IFN Beta | Measured by mRNA analysis on PBMCs | 12 weeks |
| Change in Epigenetic Expression related to IFN Gamma | Measured by mRNA analysis | 12 weeks |
| Change in Epigenetic Expression related to TNF | Measured by mRNA analysis | 12 weeks |
| Change in Epigenetic Expression related to IL-6 | Measured by mRNA analysis on PBMCs | 12 weeks |
| Dietary Changes - Energy intake (kJ/day) | Patient Reported by dietary diary | 12 weeks |
| Dietary Changes - carbohydrate intake (g/day) | Patient Reported by dietary diary | 12 weeks |
| Dietary Changes - lipid intake (g/day) | Patient Reported by dietary diary | 12 weeks |
| Dietary Changes - Protein intake (g/day) | Patient Reported by dietary diary | 12 weeks |
| Dietary Changes - Other intake (categorical) | Patient Reported by dietary diary | 12 weeks |
| Muscle Biopsy for epigenetic markers of inflammation and myokine signalling | Optional for Participants: mRNA expression of genes related to TNF, IL-6, IFN alpha, beta and Gamma signalling | 12 weeks |
| Muscle Biopsy for epigenetic markers of physical activity | Optional for Participants: NF-κB p65 DNA binding activity (ELISA), phosphorylated and total JNK, phosphorylated AMPK (p-AMPK) total AMPK (Western blotting). | 12 weeks |
| Muscle Biopsy for epigenetic markers of physical activity - NF-κB p65 DNA binding activity (ELISA) | Optional for Participants: NF-κB p65 DNA binding activity (ELISA) & NF-κB binding activity (Western blotting). | 12 weeks |
| Muscle Biopsy for epigenetic markers of physical activity - c-Jun N-terminal kinase | Optional for Participants: phosphorylated and total JNK, | 12 weeks |
| Muscle Biopsy for epigenetic markers of physical activity - AMP-activated protein kinase | Optional for Participants: phosphorylated AMPK (p-AMPK) total AMPK (Western blotting). | 12 weeks |
| Autonomic Nerve Function Test - Resting HR by Vagus(tm) | Resting heart rate measured by R-R intervals on 1-lead ECG | 12 weeks |
| Autonomic Nerve Function Test - Rise from supine ratio of RR by Vagus(tm) | Rise from supine ratio of R-R intervals on 1-lead ECG | 12 weeks |
| Autonomic Nerve Function Test - Expiration Inspiration ratio of RR by Vagus(tm) | Expiration/Inspiration ratio of R-R intervals on 1-lead ECG | 12 weeks |
| Autonomic Nerve Function Test - Valsalva Maneuver ratio of RR by Vagus(tm) | Valsalva Maneuver ratio of R-R intervals on 1-lead ECG | 12 weeks |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |