Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus with High Cardiovascular Risk: the Living Well with Lupus Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Risk cardiovascular score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The researcher responsible for performing the blood flow measurement will be blinded to the allocation of groups
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: Living well with Lupus (Behavioral)
Usual Care Group
This group will receive all regular medical care and advice healthy
Outcomes
Primary Outcomes
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
- Fatigue(6 months)
- Erythrocyte sedimentation rate(6 months)
- Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides(6 months)
- Physical activity level(6 months)
- Body mass index (BMI)(6 months)
- Waist circumference (cm)(6 months)
- Insulin sensitivity(6 months)
- Systolic and Diastolic blood pressure(6 months)
- Food consumption(6 months)
- Visceral fat(6 months)
- Peak oxygen consumption, as assessed by a cardiopulmonary exercise test(6 months)
- Endothelial function(6 months)
- Disease activity(6 months)
- Damage index(6 months)
- Global health status(6 months)
- Patients' perceptions of the intervention(6 months)
- Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description](6 months)
- Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description](6 months)
- Physical functioning assessed by Timed-Stands(6 months)
- Physical functioning assessed by Timed Up-and-Go(6 months)
- Physical functioning assessed by handgrip test(6 months)
- Anxiety(6 months)
- Depression(6 months)
- Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)(6 months)
- C-reactive protein (PCR)(6 months)
- Inflammatory markers (blood biochemistry)(6 months)
- Follow-up(Between 7 and 28 months after the completion of the intervention)
Investigators
Bruno Gualano
Professor
University of Sao Paulo