NCT03942718

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

2.1 years

First QC Date

January 25, 2019

Last Update Submit

November 5, 2022

Conditions

Systemic Lupus Erythematosus

Keywords

ExerciseAerobic trainingAnaerobic trainingInternet-based exercise program

Outcome Measures

Primary Outcomes (1)

  • Peak oxygen uptake (VO2peak)

    Change of VO2peak after 12-weeks compared to baseline.

    12-weeks

Secondary Outcomes (12)

  • Fatigue Scale for Motor and Cognitive Functions (FSMC)

    12-weeks

  • Beck Depression Inventar (BDI)

    12-weeks

  • Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)

    12-weeks

  • Disease Activity Score 28 (DAS 28)

    12-weeks

  • Work Ability Index (WAI)

    12-weeks

  • +7 more secondary outcomes

Study Arms (3)

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.

Other: Exercise

Anaerobic exercise group

EXPERIMENTAL

Participants will obtain aerobic and anaerobic exercise respectively

Other: Exercise

Interventions

ExerciseOTHER

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

Aerobic exercise groupAnaerobic exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy, Active lupus nephritits, Physical activity more than two times a week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz I. Medizinische Klinik und Poliklinik

Mainz, Rhineland-Palatinate, 55130, Germany

Location

Related Publications (2)

  • 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.

    PMID: 36443816DERIVED

  • 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.

    PMID: 33141101DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Julia Weinmann-Menke, Prof. Dr. med

    University mainz, Center of medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Nephrology and Dialysis

Study Record Dates

First Submitted

January 25, 2019

First Posted

May 8, 2019

Study Start

March 21, 2018

Primary Completion

April 25, 2020

Study Completion

August 1, 2020

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations

DE(1)