THE IMPACT OF PHYSICAL ACTIVITY AND BELIMUMAB TREATMENT ON LEVELS OF FATIGUE AND ANTI-NR2 ANTIBODIES IN SLE PATIENTS

Not Applicable

Recruiting

Conditions: Fatigue
M32.1
Systemic lupus erythematosus with organ or system involvement

Registration Number: DRKS00022933

Lead Sponsor: GlaxoSmithKline GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients aged between 18 and 75 years old, diagnosed with SLE according the ACR criteria from 2019.
Moderate or severe fatigue in the FSMC questionnaire.
Positive detection of anti-NR2 autoantibodies.
Treatment with belimumab or another immunosuppressive drug.
Informed consent by the patient.

Exclusion Criteria

No informed consent, lack of ability to consent or doubts about the ability to consent, insufficient knowledge of German, life-threatening situations, severe organ dysfunction (independent of SLE), existing pregnancy, chronic infections, a change of therapy within the last 6 weeks, diseases that can lead to fatigue (e.g. fibromyalgia, malignant diseases, presence of manifest heart involvement (pericarditis, myocarditis), anaemia, hypothyroidism or multiple sclerosis).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of fatigue score as measured with the FSMC (Fatigue Scale for Motor and Cognitive Functions) questionnaire by guided physical exercise.

Secondary Outcome Measures

Name	Time	Method
Concentration of anti-NR2 antibodies at baseline (0 weeks), after 12, 16 and 28 weeks.<br>Development of VO2max at 0, 12, 16 and 28 weeks.<br>Development of body composition at 0, 12, 16 and 28 weeks.<br>Severity of fatigue (scores: FSMC, FACIT) at 0 and 12, 16 and 28 weeks.<br>Health-related quality of life (SF-36, WAI, BDI, SLEQoL) after 0, 12, 16 and 28 weeks. <br>Disease activity (SLEDAI, BILAG, Mainzer - Lupus - Score) after 0, 12, 16 and 28 weeks.<br>Physical activity (BPAQ, IPAQ)<br>Number of complications/flares after 28 weeks.<br><br>