Healthy Lifestyle Intervention in Patients With Systemic Lupus Erythematosus: The Living Well With Lupus Study

• ClinicalTrials.gov Identifier: NCT04431167
• Recruitment Status: Not yet recruiting
• First Posted: June 16, 2020
• Last Update Posted: June 16, 2020
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Bruno Gualano, University of Sao Paulo

Tracking Information

• First Submitted Date: February 18, 2020
• First Posted Date: June 16, 2020
• Last Update Posted Date: June 16, 2020
• Estimated Study Start Date: September 1, 2020
• Estimated Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 10, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 10, 2020)

• 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
• Waist circumference (cm) [ Time Frame: 6 months ]
  assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.
• Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides [ Time Frame: 6 months ]
  assessed by blood sample analysis and combined to determine lipid profile
• Insulin sensitivity [ Time Frame: 6 months ]
  assessed by oral glucose tolerance test (OGTT)
• Systolic and Diastolic blood pressure [ Time Frame: 6 months ]
  assessed by auscultatory method with mercury sphygmomanometer
• Physical activity level [ Time Frame: 6 months ]
  assessed by thigh-mounted accelerometer (ActivPAL™ micro)
• 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)
• Visceral fat [ Time Frame: 6 months ]
  assessed by tomography
• Peak oxygen consumption, as assessed by a cardiopulmonary exercise test [ Time Frame: 6 months ]
• Endothelial function [ Time Frame: 6 months ]
  assessed by flow-mediated vasodilatation (FMD)
• 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.
• 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).
• Global health status [ Time Frame: 6 months ]
  assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.
• 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.
• 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
• 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.
• 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
• 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
• Physical functioning assessed by handgrip test [ Time Frame: 6 months ]
  Patients will be instructed to squeeze the dynamometer as hard as possible
• 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.
• 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.
• 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.
• 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.
• C-reactive protein (PCR) [ Time Frame: 6 months ]
  assessed by analysis of blood sample
• Erythrocyte sedimentation rate [ Time Frame: 6 months ]
  assessed by analysis of blood sample
• Inflammatory markers (blood biochemistry) [ Time Frame: 6 months ]
  assessed by serum cytokines

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Healthy Lifestyle Intervention in Patients With Systemic Lupus Erythematosus: The Living Well With Lupus Study
• Official Title: Healthy Lifestyle Intervention in Patients With Systemic Lupus Erythematosus With High Cardiovascular Risk: The Living Well With Lupus Study
• Brief 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. 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental group and no intervention group (usual care group)

Masking: Single (Outcomes Assessor)
Masking Description:

The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups

Primary Purpose: Treatment

• Condition: Systemic Lupus Erythematosus

Intervention

Behavioral: Living well with Lupus

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 Arms

• Experimental: Living well with Lupus Group
  A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.
  Intervention: Behavioral: Living well with Lupus
• No Intervention: Usual Care Group
  This group will receive all regular medical care and advice healthy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: June 10, 2020): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2022
• Estimated Primary Completion Date: December 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Only female participants will be eligible

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Bruno Gualano, PhD; +551130618789; gualano@usp.br

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04431167
• Other Study ID Numbers: Living well with lupus Study
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: we can share the individual data of the participants if the request is reasonable

• Responsible Party: Bruno Gualano, University of Sao Paulo
• Study Sponsor: University of Sao Paulo
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Sao Paulo
• Verification Date: June 2020