Systemic Lupus Erythematosus Exercise Program (SLEEP)

Johannes Gutenberg University (JGU)

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03942718

UniversityMedCntrMainz

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Control group

No Intervention group

Description:

Participants will obtain no exercise program. After 12 weeks, the patients in the control group will be invited to participate in the training group.

Aerobic exercise group

Experimental group

Description:

Participants will obtain aerobic exercise only.

Treatment:

Other: Exercise

Anaerobic exercise group

Experimental group

Description:

Participants will obtain aerobic and anaerobic exercise respectively

Treatment:

Other: Exercise