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

NCT ID: NCT05478018

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-01-01

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.

Conditions

Systemic Lupus Erythematosus; Interferon Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Exercise

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

Group Type: EXPERIMENTAL

High Intensity Interval Training (HIIT)

Intervention Type: BEHAVIORAL

Supervised high-intensity interval training for 12 weeks three times per week

Non-Exercise

Control group, therefore no supervised exercise regime. Subjects are asked to not increase habitual exercise routines.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High Intensity Interval Training (HIIT)

Supervised high-intensity interval training for 12 weeks three times per week

Intervention Type: BEHAVIORAL

Other Intervention Names

Aerobic Exercise

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Malte Lund Adamsen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ronan Martin G Berg, MD, DMSc

Role: STUDY_CHAIR

Center for Physical Activity Research

Iben E Rasmussen, MSc

Role: STUDY_CHAIR

Center for Physical Activity Research

Simon Jønck, MD

Role: STUDY_CHAIR

Center for Physical Activity Research

Malte L Adamsen, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Physical Activity Research

Locations

Center for Physical Activity Research

Copenhagen, , Denmark

Countries

Denmark

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

H-21039032

Identifier Type: -

Identifier Source: org_study_id