Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- University Medical Center Mainz
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Peak oxygen uptake (VO2peak)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Prof. Dr. Julia Weinmann-Menke
Head of the Department of Nephrology and Dialysis
University Medical Center Mainz
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
Outcomes
Primary Outcomes
Peak oxygen uptake (VO2peak)
Time Frame: 12-weeks
Change of VO2peak after 12-weeks compared to baseline.
Secondary Outcomes
- Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)(12-weeks)
- Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)(12-weeks)
- Muscle mass(12-weeks)
- Autoantibodies(12-weeks)
- Fatigue Scale for Motor and Cognitive Functions (FSMC)(12-weeks)
- Beck Depression Inventar (BDI)(12-weeks)
- Extra cellular vesicles (EVs)(12-weeks)
- Circulating, cell-free Deoxyribonucleic acid (CfDNA)(12-weeks)
- Disease Activity Score 28 (DAS 28)(12-weeks)
- Work Ability Index (WAI)(12-weeks)
- Ventilatory threshold (VT)(12-weeks)
- Chair-Stand-Test (CST)(12-weeks)