Systemic Lupus Erythematosus Exercise Program (SLEEP)

November 5, 2022 updated by: Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz

Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55130
        • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: Aerobic exercise group
Participants will obtain aerobic exercise only.
Other: Exercise
Participants will obtain an individualized exercise program based on entrance examination on treadmill.
Experimental: Anaerobic exercise group
Participants will obtain aerobic and anaerobic exercise respectively
Other: Exercise
Participants will obtain an individualized exercise program based on entrance examination on treadmill.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen uptake (VO2peak)
Time Frame: 12-weeks
Change of VO2peak after 12-weeks compared to baseline.
12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time Frame: 12-weeks
Change of FSMC score after 12-weeks compared to baseline. The FSMC consists of 20 items (five-point Likert scale, from "absolutely agree" to "absolutely disagree") to assess cognitive fatigue (10 items) and motor fatigue (10 items). The summed scores for cognitive and motor fatigue result in the sum score. A cut-off value of 43 indicates mild fatigue, whereas higher values are associated with moderate fatigue (≥53) or severe fatigue (≥63).
12-weeks
Beck Depression Inventar (BDI)
Time Frame: 12-weeks
Change of BDI score after 12-weeks compared to baseline to measure the severity of depression. The BDI questionnaire consists of 21 sets of statements. Each set consists of 4 statements which are ranked in terms of severity from 0 to 3. The sum of the item scores (range 0-63) indicates the severity of depression. The standardized scale is: 0-8: no depression. 9-13: minimal depression. 14-19: mild depression. 20-28: moderate depression. 29-63: severe depression.
12-weeks
Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Time Frame: 12-weeks
The Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) (SELENA-SLEDAI) will be used to measure the disease activity. The index consist of 24 items including clinical and laboratory variables to measure disease activity within the previous 10 days. The maximum score is 105. SLEDAI scores >3 indicate a mild or moderate flare, SLEDAI ≥12 indicate a severe flare.
12-weeks
Disease Activity Score 28 (DAS 28)
Time Frame: 12-weeks
Change of DAS 28 score after 12-weeks compared to baseline. The DAS 28 score indicates rheumatoid arthritis disease activity and treatment response. The score composes of 4 measures including the number of swollen/tender joints, C reactive protein and patients health assessment. A total score is calculated using the DAS 28 formula. Values range from 2.0 to 10, whereas higher values indicate higher disease activity.
12-weeks
Work Ability Index (WAI)
Time Frame: 12-weeks
The WAI self-assessment questionnaire will be used to assess the workability of the patients. The questionnaire covers six dimensions including current workability, as well as past 2 year estimation among others. The answers have different scores, which are summed to a total score, leading to four categories. 7-27 points indicate bad, 28-36 points moderate, 37-43 good, and 44-49 points very good workability.
12-weeks
Circulating, cell-free Deoxyribonucleic acid (CfDNA)
Time Frame: 12-weeks
The concentration of cfDNA (ng/ml) will be measured during and after acute exercise at baseline and after 12-weeks exercise intervention using quantitative PCR. Compared to healthy subjects SLE patients show higher cfDNA plasma levels.
12-weeks
Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)
Time Frame: 12-weeks
Change of score on RCLASI after 12-weeks compared to baseline. The RCLASI scoring system includes the RCLASI Activity Score to measure the activity of skin lesions, and the RCLASE Damage Score to measure the damage of skin lesions in patients with discoid lupus erythematosus and cutaneous lupus erythematosus. The score is used as a follow-up parameter for the Lupus activity of the skin. It was also shown that RCLASI correlates well with the physicians and patients global assessment of disease activity.
12-weeks
Extra cellular vesicles (EVs)
Time Frame: 12-weeks
The relative amount of EV subpopulations will be analyzed before and after acute exercise, as well as after 12-weeks of exercise intervention using bead isolation and or size exclusion chromatography followed by protein marker characterization.
12-weeks
Autoantibodies
Time Frame: 12-weeks
Change of antinuclear antibodies (ANA) titer after 12-weeks of exercise intervention compared to baseline (standard value ≤1:80).
12-weeks
Ventilatory threshold (VT)
Time Frame: 12-weeks
Change of VT after 12-weeks compared to baseline.
12-weeks
Muscle mass
Time Frame: 12-weeks
Change of muscle mass after 12-weeks compared to baseline. Muscle mass will be measured in absolute mass [kg] including internal organs using bioelectrical impedance analysis (InBody 3.0 Body composition analyzer).
12-weeks
Chair-Stand-Test (CST)
Time Frame: 12-weeks
Change of CST after 12-weeks compared to baseline.
12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Mainz

Collaborators

Johannes Gutenberg University Mainz

Investigators

  • Study Director: Julia Weinmann-Menke, Prof. Dr. med, University mainz, Center of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2018

Primary Completion (Actual)

April 25, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

January 25, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 5, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UniversityMedCntrMainz

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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