Back to resultsSystemic Lupus Erythematosus Exercise Program (SLEEP)
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Exercise, Aerobic training, Anaerobic training, Internet-based exercise program
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
Sites / Locations
- UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Aerobic exercise group
Anaerobic exercise group
Arm 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.
Participants will obtain aerobic exercise only.
Participants will obtain aerobic and anaerobic exercise respectively
Outcomes
Primary Outcome Measures
Peak oxygen uptake (VO2peak)
Change of VO2peak after 12-weeks compared to baseline.
Secondary Outcome Measures
Fatigue Scale for Motor and Cognitive Functions (FSMC)
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).
Beck Depression Inventar (BDI)
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.
Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
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.
Disease Activity Score 28 (DAS 28)
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.
Work Ability Index (WAI)
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.
Circulating, cell-free Deoxyribonucleic acid (CfDNA)
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.
Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)
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.
Extra cellular vesicles (EVs)
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.
Autoantibodies
Change of antinuclear antibodies (ANA) titer after 12-weeks of exercise intervention compared to baseline (standard value ≤1:80).
Ventilatory threshold (VT)
Change of VT after 12-weeks compared to baseline.
Muscle mass
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).
Chair-Stand-Test (CST)
Change of CST after 12-weeks compared to baseline.
Full Information
NCT ID
NCT03942718
First Posted
January 25, 2019
Last Updated
November 5, 2022
Sponsor
University Medical Center Mainz
Collaborators
Johannes Gutenberg University Mainz
1. Study Identification
Unique Protocol Identification Number
NCT03942718
Brief Title
Systemic Lupus Erythematosus Exercise Program
Acronym
SLEEP
Official Title
Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
April 25, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Mainz
Collaborators
Johannes Gutenberg University Mainz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Exercise, Aerobic training, Anaerobic training, Internet-based exercise program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Arm Title
Aerobic exercise group
Arm Type
Experimental
Arm Description
Participants will obtain aerobic exercise only.
Arm Title
Anaerobic exercise group
Arm Type
Experimental
Arm Description
Participants will obtain aerobic and anaerobic exercise respectively
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Participants will obtain an individualized exercise program based on entrance examination on treadmill.
Primary Outcome Measure Information:
Title
Peak oxygen uptake (VO2peak)
Description
Change of VO2peak after 12-weeks compared to baseline.
Time Frame
12-weeks
Secondary Outcome Measure Information:
Title
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Description
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).
Time Frame
12-weeks
Title
Beck Depression Inventar (BDI)
Description
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.
Time Frame
12-weeks
Title
Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Description
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.
Time Frame
12-weeks
Title
Disease Activity Score 28 (DAS 28)
Description
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.
Time Frame
12-weeks
Title
Work Ability Index (WAI)
Description
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.
Time Frame
12-weeks
Title
Circulating, cell-free Deoxyribonucleic acid (CfDNA)
Description
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.
Time Frame
12-weeks
Title
Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)
Description
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.
Time Frame
12-weeks
Title
Extra cellular vesicles (EVs)
Description
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.
Time Frame
12-weeks
Title
Autoantibodies
Description
Change of antinuclear antibodies (ANA) titer after 12-weeks of exercise intervention compared to baseline (standard value ≤1:80).
Time Frame
12-weeks
Title
Ventilatory threshold (VT)
Description
Change of VT after 12-weeks compared to baseline.
Time Frame
12-weeks
Title
Muscle mass
Description
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).
Time Frame
12-weeks
Title
Chair-Stand-Test (CST)
Description
Change of CST after 12-weeks compared to baseline.
Time Frame
12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Weinmann-Menke, Prof. Dr. med
Organizational Affiliation
University mainz, Center of medicine
Official's Role
Study Director
Facility Information:
Facility Name
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55130
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
33141101
Citation
Boedecker SC, Philippi KFA, Neuberger E, Schmidt S, Pfirrmann D, Haller N, Schwarting A, Simon P, Weinmann-Menke J. Twelve-Week Internet-Based Individualized Exercise Program in Adults With Systemic Lupus Erythematosus: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Nov 3;9(11):e18291. doi: 10.2196/18291.
Results Reference
derived
Learn more about this trial
Systemic Lupus Erythematosus Exercise Program
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