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

NCT05478018 | Completed DMC

• 1 other identifier: H-21039032
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; Interferon Deficiency

Keywords

Cardiac adaptations; Metabolic adaptations; High intensity interval training; Interleukin-6 signature; Tumor necrosis factor signature; Interferon signature

Outcome Measures

Primary Outcomes (2)

• Changes in maximal aerobic capacity (VO2max)

  Measured by VO2max test

  12 weeks

• Patient reported Fatigue

  measured by Fatigue Severity Scale Questionnaire (FSS)

  12 weeks

Secondary Outcomes (3)

• Y2K updated SLE disease activity (SLEDAI-2K) with the SELENA modifications

  12 weeks

• Short Form (SF)-36 Health Survey (0-100)

  12 weeks

• Change in Epigenetic Expression related to IFN alpha

  12 weeks

Other Outcomes (87)

• Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index-50 (SRI-50)

  12 weeks

• Visual Analog Scale (VAS) of global disease by Physician (0-100%)

  12 weeks

• Visual Analog Scale (VAS) fatigue (0-100)

  12 weeks

Study Arms (2)

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

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.

Interventions

High Intensity Interval Training (HIIT) BEHAVIORAL

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

Also known as: Aerobic Exercise

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide informed consent.
• Diagnosed SLE and fulfilling the classification criteria for SLE based on the American College of Rheumatology/EULAR criteria (SLICC)

You may not qualify if:

• Health conditions that prevent participating in the exercise intervention determined by the Research Coordinator these include but are not limited to
• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen Lupus and Vasculitis Clinic, Center for Rheumatology and Spine Diseases, Rigshospitalet: collaborator

Study Sites (1)

Center for Physical Activity Research

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

High-Intensity Interval Training; Exercise

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 28, 2022
• Study Start: April 1, 2022
• Primary Completion: April 16, 2024
• Study Completion: January 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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 Criteria: 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

Locations

DK (1)