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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04431167
• Other study ID #: Living well with lupus Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2020
• Source: University of Sao Paulo
• Contact: Bruno Gualano, PhD
• Phone: +551130618789
• Email: gualano[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Secondary	Body mass index (BMI)	assessed by weight (kg) and height (m) that will be combined to report BMI in kg/m^2	6 months
Secondary	Waist circumference (cm)	assessed by measuring tape positioned at the midpoint between the last floating vertebra and the iliac crest.	6 months
Secondary	Total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides	assessed by blood sample analysis and combined to determine lipid profile	6 months
Secondary	Insulin sensitivity	assessed by oral glucose tolerance test (OGTT)	6 months
Secondary	Systolic and Diastolic blood pressure	assessed by auscultatory method with mercury sphygmomanometer	6 months
Secondary	Physical activity level	assessed by thigh-mounted accelerometer (ActivPAL™ micro)	6 months
Secondary	Food consumption	assessed by three 24-hour food recall in non-consecutive days (being one of the days on the weekend)	6 months
Secondary	Visceral fat	assessed by tomography	6 months
Secondary	Peak oxygen consumption, as assessed by a cardiopulmonary exercise test		6 months
Secondary	Endothelial function	assessed by flow-mediated vasodilatation (FMD)	6 months
Secondary	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.	6 months
Secondary	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).	6 months
Secondary	Global health status	assessed by the Visual Analogic Scale (0 and 10 scale). Higher values represent worst global health status.	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Physical functioning assessed by handgrip test	Patients will be instructed to squeeze the dynamometer as hard as possible	6 months
Secondary	Fatigue	assessed by Fatigue Scale (FACIT). The final score can vary from 0 to 52, where higher final score representing higher level of fatigue.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	C-reactive protein (PCR)	assessed by analysis of blood sample	6 months
Secondary	Erythrocyte sedimentation rate	assessed by analysis of blood sample	6 months
Secondary	Inflammatory markers (blood biochemistry)	assessed by serum cytokines	6 months