Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2013-06-30
2014-07-31
Brief Summary
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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.
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Detailed Description
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A 12 month, randomized single blind clinical trial was conducted to determine whether long-term exercise and dietary weight loss are more efficacious, either separately or in combination, than standard care alone in improving physical function, pain, fatigue, depression and systemic inflammation in obese adults with PsA.
Fifty-five obese ethnically homogenous adult PsA patients with a body mass index (BMI) ≥30, who satisfied the classification of psoriatic arthritis criteria were recruited. Patients were randomized into usual lifestyle (controls), diet only, exercise only, and diet plus exercise groups together with the continued use of standard treatment.
Exclusion criteria included other inflammatory conditions. Detailed skin and rheumatological assessment was conducted. Disease activity was assessed by psoriasis area and severity index (PASI), disease activity score (DAS28CRP), Health Assessment Questionnaire- Disability Index (HAQ-DI), Beck's Depression Inventory (BDI) and fatigue numeric rating scale. 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, systemic inflammation markers, BMI, physical function, pain, fatigue, depression and HAQ-DI. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diet
Low-fat diet
Diet
Exercise
3-day/week exercise programme
Exercise
Diet and exercise
healthy low fat diet and 3day/week exercise programme
Diet and Exercise
Healthy lifestyle (Control) group
Control group was provided with health education using videotaped presentation
Healthy Lifestyle (Control) Group
Interventions
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Diet
Exercise
Diet and Exercise
Healthy Lifestyle (Control) Group
Eligibility Criteria
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Inclusion Criteria
* Must satisfy the classification of psoriatic arthritis criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Alexandria
OTHER
Responsible Party
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Anna Abou-Raya
MD
Principal Investigators
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Anna Abou-Raya, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alexandria
Locations
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University of Alexandria
Alexandria, Alexandria Governorate, Egypt
Countries
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Other Identifiers
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alexmed12671300
Identifier Type: -
Identifier Source: org_study_id
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