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Systemic Lupus ErythematosusNCT04431167

Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study

A study testing Living well with Lupus in people with Systemic Lupus Erythematosus, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research program aims to investigate the clinical, physiological, metabolic and molecular effects of lifestyle change in patients with systemic lupus erythematosus with high cardiovascular risk. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Living well with Lupus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteBrazil
Study dates
1 Dec 2020to 28 Aug 2023
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women between 18 and 65 years old diagnosed with systemic lupus erythematosus
  • one or more high cardiovascular risk factors
  • SLEDAI score ≤ 4
  • Treatment with prednisone at a dosage <10 mg/d and treatment with hydroxychloroquine in a stable dose

Who cannot join

  • another rheumatic diseases (except for secondary Sjogren's syndrome)
  • participation in structured exercise training programs and/or prescriptive diets
  • illiterate or with diagnosed cognitive disorders or musculoskeletal impairments that potentially compromise understanding and participation in the intervention

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

Official title: Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus with High Cardiovascular Risk: the Living Well with Lupus Study

This research program aims to investigate the clinical, physiological, metabolic and molecular effects of lifestyle change in patients with systemic lupus erythematosus with high cardiovascular risk. This 6-month parallel-group randomized controlled trial aims to investigate the feasibility and efficacy of a newly developed lifestyle change intervention - through recommendations for structured and unstructured physical activity and healthy eating - on increasing physical activity level and improving eating habits. Potential effects of the intervention on cardiovascular and cardiometabolic risk factors, health-related quality of life, symptoms of anxiety and depression, sleep quality and immune function will be investigated. Gold-standard techniques and a variety of analyses will be performed to access the potential mechanisms involved in response to this intervention.

Being tested
Living well with Lupus
Keywords
Life style, Behavioral intervention, Cardiovascular risk, Life quality
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Living well with LupusBehavioural

    The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.

Study groups in NCT04431167
Study groupRoleWhat they receive
Living well with Lupus GroupExperimentalA newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.
Receives: Behavioral: Living well with Lupus
Usual Care GroupNo interventionThis group will receive all regular medical care and advice healthy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risk cardiovascular score

    assessed by measures of five standard variables (HDL cholesterol, triglycerides, fasting blood glucose, waist circumference and blood pressure - average of systolic and diastolic blood pressures). Z-score = [(50 - HDL cholesterol)/sd + (triglycerides - 150)/ sd] + [(fasting blood glucose - 100)/ sd] + [(waist circumference - 88)/ sd] + [(blood pressure - 115)/ sd]. Higher score values represent higher risk. *sd: standard deviation. Higher Z-score represent higher risk.

    Measured: 6 months

Secondary outcomes (27)

  1. Body mass index (BMI)

    assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m^2

    Measured: 6 months

  2. Waist circumference (cm)

    assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.

    Measured: 6 months

  3. Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides

    assessed by blood sample analysis and combined to determine lipid profile

    Measured: 6 months

  4. Insulin sensitivity

    assessed by oral glucose tolerance test (OGTT)

    Measured: 6 months

  5. Systolic and Diastolic blood pressure

    assessed by auscultatory method with mercury sphygmomanometer

    Measured: 6 months

  6. Physical activity level

    assessed by thigh-mounted accelerometer (ActivPAL™ micro)

    Measured: 6 months

  7. Food consumption

    assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)

    Measured: 6 months

  8. Visceral fat

    assessed by tomography

    Measured: 6 months

  9. Peak oxygen consumption, as assessed by a cardiopulmonary exercise test

    Measured: 6 months

  10. Endothelial function

    assessed by flow-mediated vasodilatation (FMD)

    Measured: 6 months

  11. Disease activity

    The activity of the disease, which will be impaired by safety, will be assessed by the presence of anti-dsDNA, using the ELISA technique and confirmation by indirect immunofluorescence in Crithidia luciliae and assessed by the questionnaire Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2000). Total score ranges from 0 to 105. Higher scores represent higher disease activity.

    Measured: 6 months

  12. Damage index

    assessed by Systemic Lupus International Collaborating Clinics/ American College of Rheumatology - Damage Index. Total score range from 0 (no damage) to 46 (maximum damage).

    Measured: 6 months

  13. Global health status

    assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.

    Measured: 6 months

  14. Patients' perceptions of the intervention

    assessed by focus group. A semi-structured script composed of open questions about intervention positive and negative points, barriers for physical activity practice and changes in food consumption, perceptions of health improvement or worsening (physical and psychological aspects), well-being, motivation to maintain the changes made, perspectives regarding health and disease.

    Measured: 6 months

  15. Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description]

    maximum score is 100, with higher scores representing better life quality

    Measured: 6 months

  16. Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description]

    score ranges from 40 to 280 with higher scores represent worst life quality.

    Measured: 6 months

  17. Physical functioning assessed by Timed-Stands

    evaluates the maximum number of stand-ups that a subject could perform from a standard height (i.e., 45 cm) armless chair within 30 s

    Measured: 6 months

  18. Physical functioning assessed by Timed Up-and-Go

    evaluates the time required for the subject to rise from a standard arm chair, walk towards a line drawn on the floor three meters away, turn, return, and sit back down again

    Measured: 6 months

  19. Physical functioning assessed by handgrip test

    Patients will be instructed to squeeze the dynamometer as hard as possible

    Measured: 6 months

  20. Fatigue

    assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.

    Measured: 6 months

  21. Anxiety

    assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-A. Total score ranges from 0 to 21. Where higher final score representing higher level.

    Measured: 6 months

  22. Depression

    assessed by sub-scale of Hospital Anxiety and Depression Scale (HADS), called HADS-D. Total score ranges from 0 to 21. Where higher final score representing higher level.

    Measured: 6 months

  23. Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)

    Data from actigraph will come as these measures: Total Sleep Time (hours/day), Sleep Efficiency (%), Sleep Onset Latency (min), and Wake After Sleep Onset (min), and this data will be considered to determine the sleep quality.

    Measured: 6 months

  24. C-reactive protein (PCR)

    assessed by analysis of blood sample

    Measured: 6 months

  25. Erythrocyte sedimentation rate

    assessed by analysis of blood sample

    Measured: 6 months

  26. Inflammatory markers (blood biochemistry)

    assessed by serum cytokines

    Measured: 6 months

  27. Follow-up

    investigate the long-term effects of the intervention on maintenance of lifestyle behaviors and its effects on health

    Measured: Between 7 and 28 months after the completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start1 Dec 2020
  3. Primary completion28 Feb 2023
  4. Study completion28 Aug 2023

Resources

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
Experimental group and no intervention group (usual care group)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04431167
Sponsor's protocol ID
Living well with lupus Study
Status last verified
Dec 2024
First submitted
18 Feb 2020
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we can share the individual data of the participants if the request is reasonable

Publications

  • Caruso Mazzolani B, Infante Smaira F, Mendes Sieczkowska S, Romero M, C Santo Andre H, G Pasoto S, de Sa Pinto AL, Rodrigues Lima F, Braga Benatti F, Roschel H, Weber MB, Gualano B. Acceptability and impact of a lifestyle intervention for systemic lupus erythematosus: Qualitative analysis of living well with lupus study. Lupus. 2025 Apr;34(5):474-483. doi: 10.1177/09612033251326986. Epub 2025 Mar 13.

    PubMed 40083122

  • Sieczkowska SM, Mazzolani BC, Smaira FI, Romero M, Pasoto SG, de Sa Pinto AL, Lima FR, De Oliveira VR, Ueda S, Benatti FB, Roschel H, Gualano B. Effects of a lifestyle intervention on cardiovascular risk factors in systemic lupus erythematosus patients: The study "Living well with lupus". Clin Rheumatol. 2024 Mar;43(3):1003-1013. doi: 10.1007/s10067-024-06870-2. Epub 2024 Jan 27.

    PubMed 38280124

  • Sieczkowska SM, Smaira FI, Mazzolani BC, Romero M, Pasoto SG, de Sa Pinto AL, Lima FR, De Oliveira VR, Ueda S, Benatti FB, Roschel H, Gualano B. A randomized controlled trial of an intervention promoting physical activity and healthy eating recommendations in systemic lupus erythematosus: the protocol study "Living Well with Lupus". Rheumatol Int. 2023 Oct;43(10):1799-1810. doi: 10.1007/s00296-023-05370-x. Epub 2023 Jun 24.

    PubMed 37354245

Questions about this trial

What is this clinical trial studying?

A study testing Living well with Lupus in people with Systemic Lupus Erythematosus, run by University of Sao Paulo at 1 site in Brazil.

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 4 inclusion and 3 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 11 Dec 2024. 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 Brazil. 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?

Risk cardiovascular score (time frame: 6 months). 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 NCT04431167, which also lists 3 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 11 Dec 2024.

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