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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
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.
Time frame: 6 months
Body mass index (BMI)
assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m\^2
Time frame: 6 months
Waist circumference (cm)
assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.
Time frame: 6 months
Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
assessed by blood sample analysis and combined to determine lipid profile
Time frame: 6 months
Insulin sensitivity
assessed by oral glucose tolerance test (OGTT)
Time frame: 6 months
Systolic and Diastolic blood pressure
assessed by auscultatory method with mercury sphygmomanometer
Time frame: 6 months
Physical activity level
assessed by thigh-mounted accelerometer (ActivPAL™ micro)
Time frame: 6 months
Food consumption
assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)
Time frame: 6 months
Visceral fat
assessed by tomography
Time frame: 6 months
Peak oxygen consumption, as assessed by a cardiopulmonary exercise test
Time frame: 6 months
Endothelial function
assessed by flow-mediated vasodilatation (FMD)
Time frame: 6 months
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.
Time frame: 6 months
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).
Time frame: 6 months
Global health status
assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
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.
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
Physical functioning assessed by handgrip test
Patients will be instructed to squeeze the dynamometer as hard as possible
Time frame: 6 months
Fatigue
assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
C-reactive protein (PCR)
assessed by analysis of blood sample
Time frame: 6 months
Erythrocyte sedimentation rate
assessed by analysis of blood sample
Time frame: 6 months
Inflammatory markers (blood biochemistry)
assessed by serum cytokines
Time frame: 6 months
Follow-up
investigate the long-term effects of the intervention on maintenance of lifestyle behaviors and its effects on health
Time frame: Between 7 and 28 months after the completion of the intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.