Systemic Lupus ErythematosusSLEEPNCT03942718
Systemic Lupus Erythematosus Exercise Program
A study testing Exercise in people with Systemic Lupus Erythematosus, run by University Medical Center Mainz at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 Mar 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy, Active lupus nephritits, Physical activity more than two times a week
Trial locations and contacts
1 site in 1 country.
Germany1 site
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik
Mainz, Rhineland-Palatinate, 55130
About this study
Official title: 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).
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Exercise
- Keywords
- Exercise, Aerobic training, Anaerobic training, Internet-based exercise program
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Participants will obtain an individualized exercise program based on entrance examination on treadmill.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | Participants will obtain aerobic exercise only. Receives: Other: Exercise |
| Anaerobic exercise group | Experimental | Participants will obtain aerobic and anaerobic exercise respectively Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake (VO2peak)
Change of VO2peak after 12-weeks compared to baseline.
Measured: 12-weeks
Secondary outcomes (12)
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).
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
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.
Measured: 12-weeks
Autoantibodies
Change of antinuclear antibodies (ANA) titer after 12-weeks of exercise intervention compared to baseline (standard value ≤1:80).
Measured: 12-weeks
Ventilatory threshold (VT)
Change of VT after 12-weeks compared to baseline.
Measured: 12-weeks
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).
Measured: 12-weeks
Chair-Stand-Test (CST)
Change of CST after 12-weeks compared to baseline.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start21 Mar 2018
- Primary completion25 Apr 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Principal investigator, Prof. Dr. Julia Weinmann-Menke, University Medical Center Mainz
- Investigators
- Julia Weinmann-Menke, Prof. Dr. med, Study director, University mainz, Center of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942718
- Sponsor's protocol ID
- UniversityMedCntrMainz
- Acronym
- SLEEP
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2019
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pisareva E, Mihalovicova L, Pastor B, Kudriavtsev A, Mirandola A, Mazard T, Badiou S, Maus U, Ostermann L, Weinmann-Menke J, Neuberger EWI, Simon P, Thierry AR. Neutrophil extracellular traps have auto-catabolic activity and produce mononucleosome-associated circulating DNA. Genome Med. 2022 Nov 28;14(1):135. doi: 10.1186/s13073-022-01125-8.
PubMed 36443816Boedecker 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.
PubMed 33141101
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03942718
- Acronym / sponsor ID
- SLEEP / UniversityMedCntrMainz
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Exercise, Aerobic training, Anaerobic training, Internet-based exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Other: ExerciseParticipants will obtain aerobic exercise only. |
| Anaerobic exercise group | Experimental | Other: ExerciseParticipants will obtain aerobic and anaerobic exercise respectively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Pregnancy, Active lupus nephritits, Physical activity more than two times a week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants will obtain an individualized exercise program based on entrance examination on treadmill. | Other | Aerobic exercise group, Anaerobic exercise group |
Primary outcome
Peak oxygen uptake (VO2peak)
Time frame: 12-weeks
Change of VO2peak after 12-weeks compared to baseline.
12 secondary outcomes
Fatigue Scale for Motor and Cognitive Functions (FSMC)
Time frame: 12-weeks
Beck Depression Inventar (BDI)
Time frame: 12-weeks
Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)
Time frame: 12-weeks
Disease Activity Score 28 (DAS 28)
Time frame: 12-weeks
Work Ability Index (WAI)
Time frame: 12-weeks
Circulating, cell-free Deoxyribonucleic acid (CfDNA)
Time frame: 12-weeks
Revised Cutaneous Lupus Erythematosus Disease Area and Severity Index (RCLASI)
Time frame: 12-weeks
Extra cellular vesicles (EVs)
Time frame: 12-weeks
Autoantibodies
Time frame: 12-weeks
Ventilatory threshold (VT)
Time frame: 12-weeks
Muscle mass
Time frame: 12-weeks
Chair-Stand-Test (CST)
Time frame: 12-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 36443816Pisareva E, Mihalovicova L, Pastor B, Kudriavtsev A, Mirandola A, Mazard T, Badiou S, Maus U, Ostermann L, Weinmann-Menke J, Neuberger EWI, Simon P, Thierry AR. Neutrophil extracellular traps have auto-catabolic activity and produce mononucleosome-associated circulating DNA. Genome Med. 2022 Nov 28;14(1):135. doi: 10.1186/s13073-022-01125-8.
- Derived from this study: PubMed 33141101Boedecker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Weinmann-Menke, Prof. Dr. med study director
University mainz, Center of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Systemic Lupus Erythematosus, run by University Medical Center Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (VO2peak) (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.