Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Behavioral: Living well with Lupus
- Registration Number
- NCT04431167
- Lead Sponsor
- University of Sao Paulo
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Living well with Lupus Group Living well with Lupus A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.
- Primary Outcome Measures
Name Time Method Risk cardiovascular score 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 Outcome Measures
Name Time Method Body mass index (BMI) 6 months assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m\^2
Waist circumference (cm) 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 6 months assessed by blood sample analysis and combined to determine lipid profile
Insulin sensitivity 6 months assessed by oral glucose tolerance test (OGTT)
Systolic and Diastolic blood pressure 6 months assessed by auscultatory method with mercury sphygmomanometer
Physical activity level 6 months assessed by thigh-mounted accelerometer (ActivPAL™ micro)
Food consumption 6 months assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)
Visceral fat 6 months assessed by tomography
Peak oxygen consumption, as assessed by a cardiopulmonary exercise test 6 months Endothelial function 6 months assessed by flow-mediated vasodilatation (FMD)
Disease activity 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 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 6 months assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.
Patients' perceptions of the intervention 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] 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] 6 months score ranges from 40 to 280 with higher scores represent worst life quality.
Physical functioning assessed by Timed-Stands 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 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 6 months Patients will be instructed to squeeze the dynamometer as hard as possible
Fatigue 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 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 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) 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) 6 months assessed by analysis of blood sample
Erythrocyte sedimentation rate 6 months assessed by analysis of blood sample
Inflammatory markers (blood biochemistry) 6 months assessed by serum cytokines
Follow-up 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
Trial Locations
- Locations (1)
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷São Paulo, Brazil