Effect of Exercise and Diet on Psoriatic Arthritis
NCT02188641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2014-07-11
Summary
Psoriatic arthritis (PsA) is a particular pattern of inflammatory arthritis often seen in association with psoriasis. PsA patients have a higher prevalence of comorbidities including obesity, metabolic syndrome, depression and premature cardiovascular disease. There is evidence that obesity is associated with PsA. A 12 month study was conducted to determine whether exercise and dietary weight loss are more efficacious, either separately or in combination, than standard care alone in improving symptoms and signs in obese adults with PsA.
Fifty-five obese PsA patients with a body mass index (BMI) ≥30, were recruited. Patients were randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise groups for 12 months. Disease activity was assessed. Blood samples collected after 12 hours overnight fasting were analysed for glucose, lipid profile, ESR, hsCRP, proinflammatory cytokines; tumour necrosis factor alpha (TNF-alpha), interleukin-6 (IL-6) and interleukin-17 (IL-17). The primary outcome measures included improvement in ACR20. Secondary endpoints included reduction in PASI score, DAS28-CRP response and physician and patient global assessment (PGA). Safety and tolerability were also assessed. Data was collected at baseline and every 6 months.
Conditions
Interventions
- OTHER
-
Diet
- OTHER
-
Exercise
- OTHER
-
Diet and Exercise
- OTHER
-
Healthy Lifestyle (Control) Group
Sponsors & Collaborators
-
University of Alexandria
lead OTHER
Principal Investigators
-
Anna Abou-Raya, MD · University of Alexandria
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- Egypt
Study Locations
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