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Systemic Lupus Erythematosus Exercise Program (SLEEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942718
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz

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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Other: Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Peak oxygen uptake (VO2peak) [ Time Frame: 12-weeks ]
    Change of VO2peak after 12-weeks compared to baseline.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Autoantibodies [ Time Frame: 12-weeks ]
    Change of antinuclear antibodies (ANA) titer after 12-weeks of exercise intervention compared to baseline (standard value ≤1:80).

  10. Ventilatory threshold (VT) [ Time Frame: 12-weeks ]
    Change of VT after 12-weeks compared to baseline.

  11. 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. Chair-Stand-Test (CST) [ Time Frame: 12-weeks ]
    Change of CST after 12-weeks compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942718


Contacts
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Contact: Julia Weinmann-Menke, Prof. Dr. med 00496131/172462 julia.weinmann-menke@unimedizin-mainz.de
Contact: Perikles Simon, Prof. Dr. Dr. 00496131-3923 586 simonpe@uni-mainz.de

Locations
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Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik Recruiting
Mainz, Rheinland-Pfalz, Germany, 55130
Contact: Julia Weinmann-Menke, Prof. Dr. med.    00496131 172462    weinmann-menke@unimedizin‐mainz.de   
Contact: Simone C Boedecker, Dr. med.    00496131-172213    SimoneCosima.Boedecker@unimedizin-mainz.de   
Sponsors and Collaborators
University Medical Center Mainz
Johannes Gutenberg University Mainz
Investigators
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Study Director: Julia Weinmann-Menke, Prof. Dr. med University mainz, Center of medicine

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Responsible Party: Prof. Dr. Julia Weinmann-Menke, Prof. Dr., University Medical Center Mainz
ClinicalTrials.gov Identifier: NCT03942718    
Other Study ID Numbers: UniversityMedCntrMainz
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz:
Exercise
Aerobic training
Anaerobic training
Internet-based exercise program
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases