Healthy Lifestyle Intervention in Patients with Systemic Lupus Erythematosus: the Living Well with Lupus Study

University of Sao Paulo

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Behavioral: Living well with Lupus

Study type: Interventional

Funder types: Other

Identifiers

NCT04431167

Living well with lupus Study

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Living well with Lupus Group

Experimental group

Description:

A newly developed intervention focused on promoting lifestyle change through recommendations for structured and unstructured physical activity and healthy eating.

Treatment:

Behavioral: Living well with Lupus

Usual Care Group

No Intervention group

Description:

This group will receive all regular medical care and advice healthy