Systemic Lupus Erythematosus Exercise Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic exercise group

Participants will obtain aerobic exercise only.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Participants will obtain an individualized exercise program based on entrance examination on treadmill.

Anaerobic exercise group

Participants will obtain aerobic and anaerobic exercise respectively

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Participants will obtain an individualized exercise program based on entrance examination on treadmill.

Interventions

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Exercise

Participants will obtain an individualized exercise program based on entrance examination on treadmill.

Intervention Type OTHER

Eligibility Criteria

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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