Systemic Lupus ErythematosusLUPEXNCT05478018
Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus Erythematosus Patients
A study testing High Intensity Interval Training (HIIT) in people with Systemic Lupus Erythematosus and Interferon Deficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Interferon Deficiency
- What is being tested?
- High Intensity Interval Training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus
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.
Read the 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.
- Being tested
- High Intensity Interval Training (HIIT)
- Keywords
- Cardiac adaptations, Metabolic adaptations, High intensity interval training, Interleukin-6 signature, Tumor necrosis factor signature, Interferon signature
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval Training (HIIT)Behavioural
Also called Aerobic Exercise
Supervised high-intensity interval training for 12 weeks three times per week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: High Intensity Interval Training (HIIT) |
| Non-Exercise | No intervention | Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in maximal aerobic capacity (VO2max)
Measured by VO2max test
Measured: 12 weeks
Patient reported Fatigue
measured by Fatigue Severity Scale Questionnaire (FSS)
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 12 weeks
Short Form (SF)-36 Health Survey (0-100)
Patient reported outcome measures (PROMs), Possible scores range from 0 to 100, with higher scores representing better health status
Measured: 12 weeks
Change in Epigenetic Expression related to IFN alpha
Measured by mRNA analysis
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Apr 2022
- Primary completion16 Apr 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet
- Responsible party
- Principal investigator, Malte Lund Adamsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ronan Martin G Berg, MD, DMSc, Study chair, Center for Physical Activity ResearchIben E Rasmussen, MSc, Study chair, Center for Physical Activity ResearchSimon Jønck, MD, Study chair, Center for Physical Activity ResearchMalte L Adamsen, MD, Principal investigator, Center for Physical Activity Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478018
- Sponsor's protocol ID
- H-21039032
- Acronym
- LUPEX
- Status last verified
- Sep 2025
- First submitted
- 21 Jul 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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 Aug;162:103595. doi: 10.1016/j.jaut.2026.103595. Epub 2026 Jul 8.
PubMed 42419149
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Interferon Induced Changes to Exercise Adaptations in Systemic Lupus
- ClinicalTrials.gov ID
- NCT05478018
- Acronym / sponsor ID
- LUPEX / H-21039032
- Keywords
- Cardiac adaptations, Metabolic adaptations, High intensity interval training, Interleukin-6 signature, Tumor necrosis factor signature, Interferon signature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 16 Apr 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: High Intensity Interval Training (HIIT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Interval Training (HIIT)Also: Aerobic ExerciseSupervised high-intensity interval training for 12 weeks three times per week | Behavioural | Exercise |
Primary outcome
Changes in maximal aerobic capacity (VO2max)
Time frame: 12 weeks
Measured by VO2max test
Patient reported Fatigue
Time frame: 12 weeks
measured by Fatigue Severity Scale Questionnaire (FSS)
3 secondary outcomes
Y2K updated SLE disease activity (SLEDAI-2K) with the SELENA modifications
Time frame: 12 weeks
Short Form (SF)-36 Health Survey (0-100)
Time frame: 12 weeks
Change in Epigenetic Expression related to IFN alpha
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 42419149Adamsen 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 3
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis
Lupus Nephritis
Not yet recruitingPhase 2/3
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan Martin G Berg, MD, DMSc study chair
Center for Physical Activity Research
Iben E Rasmussen, MSc study chair
Center for Physical Activity Research
Simon Jønck, MD study chair
Center for Physical Activity Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training (HIIT) in people with Systemic Lupus Erythematosus and Interferon Deficiency, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in maximal aerobic capacity (VO2max) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.