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NCT Number: NCT04431167

Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05403-010, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Living well with Lupus

Behavioral

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.

Primary outcomes

  1. Risk cardiovascular score

    Time frame: 6 months

    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.

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: 6 months

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

  2. Waist circumference (cm)

    Time frame: 6 months

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

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

    Time frame: 6 months

    assessed by blood sample analysis and combined to determine lipid profile

  4. Insulin sensitivity

    Time frame: 6 months

    assessed by oral glucose tolerance test (OGTT)

  5. Systolic and Diastolic blood pressure

    Time frame: 6 months

    assessed by auscultatory method with mercury sphygmomanometer

  6. Physical activity level

    Time frame: 6 months

    assessed by thigh-mounted accelerometer (ActivPAL™ micro)

  7. Food consumption

    Time frame: 6 months

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

  8. Visceral fat

    Time frame: 6 months

    assessed by tomography

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

    Time frame: 6 months

  10. Endothelial function

    Time frame: 6 months

    assessed by flow-mediated vasodilatation (FMD)

  11. Disease activity

    Time frame: 6 months

    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.

  12. Damage index

    Time frame: 6 months

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

  13. Global health status

    Time frame: 6 months

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

  14. Patients' perceptions of the intervention

    Time frame: 6 months

    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.

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

  17. Physical functioning assessed by Timed-Stands

    Time frame: 6 months

    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

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

    Time frame: 6 months

    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

  19. Physical functioning assessed by handgrip test

    Time frame: 6 months

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

  20. Fatigue

    Time frame: 6 months

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

  21. Anxiety

    Time frame: 6 months

    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.

  22. Depression

    Time frame: 6 months

    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.

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

    Time frame: 6 months

    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.

  24. C-reactive protein (PCR)

    Time frame: 6 months

    assessed by analysis of blood sample

  25. Erythrocyte sedimentation rate

    Time frame: 6 months

    assessed by analysis of blood sample

  26. Inflammatory markers (blood biochemistry)

    Time frame: 6 months

    assessed by serum cytokines

  27. Follow-up

    Time frame: Between 7 and 28 months after the completion of the intervention

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2020
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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