Effect of Exercise and Diet on Psoriatic Arthritis
EFFECT OF EXERCISE AND DIETARY WEIGHT LOSS ON SYMPTOMS AND SYSTEMIC INFLAMMATION IN OBESE ADULTS WITH PSORIATIC ARTHRITIS: RANDOMIZED CONTROLLED TRIAL
1 other identifier
interventional
55
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedJuly 11, 2014
July 1, 2014
1.1 years
July 4, 2014
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR20 response
12 months
Secondary Outcomes (4)
PASI score
12 months
DAS28-CRP response
12 months
physician global assessment (PGA)
12 months
patient global assessment (PGA)
12 months
Study Arms (4)
Diet
OTHERLow-fat diet
Exercise
OTHER3-day/week exercise programme
Diet and exercise
OTHERhealthy low fat diet and 3day/week exercise programme
Healthy lifestyle (Control) group
OTHERControl group was provided with health education using videotaped presentation
Interventions
Eligibility Criteria
You may qualify if:
- PsA patients with a body mass index (BMI) ≥30
- Must satisfy the classification of psoriatic arthritis criteria
You may not qualify if:
- Other inflammatory conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alexandria
Alexandria, Alexandria Governorate, 00203, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Abou-Raya, MD
University of Alexandria
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 11, 2014
Study Start
June 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 11, 2014
Record last verified: 2014-07