Clinical trial NCT04431167: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Life style
Behavioral intervention
Cardiovascular risk
Life quality
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group and no intervention group (usual care group)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Risk cardiovascular score
timeFrame: 6 months
Secondary outcomes:
measure: Body mass index (BMI)
timeFrame: 6 months
measure: Waist circumference (cm)
timeFrame: 6 months
measure: Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides
timeFrame: 6 months
measure: Insulin sensitivity
timeFrame: 6 months
measure: Systolic and Diastolic blood pressure
timeFrame: 6 months
measure: Physical activity level
timeFrame: 6 months
measure: Food consumption
timeFrame: 6 months
measure: Visceral fat
timeFrame: 6 months
measure: Peak oxygen consumption, as assessed by a cardiopulmonary exercise test
timeFrame: 6 months
measure: Endothelial function
timeFrame: 6 months
measure: Disease activity
timeFrame: 6 months
measure: Damage index
timeFrame: 6 months
measure: Global health status
timeFrame: 6 months
measure: Patients' perceptions of the intervention
timeFrame: 6 months
measure: Quality of Life assesment assessed by the Short-Form Health Survey-36 (SF36) [followed by its scale information in the Description]
timeFrame: 6 months
measure: Quality of Life assessed by Systemic Lupus Erythematosus Quality of Life Questionnaire ( SLEQOL) [followed by its scale information in the Description]
timeFrame: 6 months
measure: Physical functioning assessed by Timed-Stands
timeFrame: 6 months
measure: Physical functioning assessed by Timed Up-and-Go
timeFrame: 6 months
measure: Physical functioning assessed by handgrip test
timeFrame: 6 months
measure: Fatigue
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
measure: Depression
timeFrame: 6 months
measure: Sleep quality assessed by data obtained from Actigraph (Actigraph GT3x)
timeFrame: 6 months
measure: C-reactive protein (PCR)
timeFrame: 6 months
measure: Erythrocyte sedimentation rate
timeFrame: 6 months
measure: Inflammatory markers (blood biochemistry)
timeFrame: 6 months
measure: Follow-up
timeFrame: Between 7 and 28 months after the completion of the intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
References: