Clinical trial NCT03942718: Systemic Lupus Erythematosus Exercise Program
Official title: Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Exercise
Aerobic training
Anaerobic training
Internet-based exercise program
Lead sponsor: University Medical Center Mainz
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2019-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The three study arms (TAU, aerobic exercise, anerobic exercise) will be included in parallel. After 12 weeks, the patients in the control group will be invited to participate in the training group.
Primary purpose: TREATMENT

Brief summary: This pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to treatment-as-usual (TAU).

Detailed description: The aim of this study is to evaluate the effect of a 12-week individualized exercise program in subjects with SLE in comparison to treatment-as-usual therapy. Several previous studies showed that exercise leads to various benefits in treating SLE, including enhanced aerobic capacity, reduced symptoms of depression and fatigue. Moreover, it has been shown that exercise is well tolerated and does not impair disease activity in SLE negatively. Here, the effects of an individual internet-based exercise therapy for 12 weeks will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Positive ANA-titer (≥ 1:80) or Anti-dsDNA (≥ 200 IU/ml) or Highly avid-dsDNA autoantibody (≥ 30 IU/ml)
* Stable immunosuppressive therapy more than 30 days before beginning of the study with steroid (0-20 mg/day) or other immunosuppressive medication like Hydroxchloroquin, Chloroquin, Azathioprin, Methotrexat, Mycophenolatmofetil, Cyclosporin, Belimumab, Rituximab

Exclusion Criteria:

* Pregnancy, Active lupus nephritits, Physical activity more than two times a week

Primary outcomes:
measure: Peak oxygen uptake (VO2peak)
timeFrame: 12-weeks
Secondary outcomes:
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: 12-weeks
measure: Beck Depression Inventar (BDI)
timeFrame: 12-weeks
measure: Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
timeFrame: 12-weeks
measure: Disease Activity Score 28 (DAS 28)
timeFrame: 12-weeks
measure: Work Ability Index (WAI)
timeFrame: 12-weeks
measure: Circulating, cell-free Deoxyribonucleic acid (CfDNA)
timeFrame: 12-weeks
measure: Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)
timeFrame: 12-weeks
measure: Extra cellular vesicles (EVs)
timeFrame: 12-weeks
measure: Autoantibodies
timeFrame: 12-weeks
measure: Ventilatory threshold (VT)
timeFrame: 12-weeks
measure: Muscle mass
timeFrame: 12-weeks
measure: Chair-Stand-Test (CST)
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
state: Rheinland-Pfalz
Study officials:
affiliation: University mainz, Center of medicine
name: Julia Weinmann-Menke, Prof. Dr. med
role: STUDY_DIRECTOR
References:
citation: Boedecker SC, Philippi KFA, Neuberger E, Schmidt S, Pfirrmann D, Haller N, Schwarting A, Simon P, Weinmann-Menke J. Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 3;9(11):e18291. doi: 10.2196/18291.