Effect of Exercise and Diet on Psoriatic Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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There is evidence that obesity is associated with PsA. Obesity leads to increased proinflammatory cytokines which may contribute to the development of multiple disturbances in PsA patients. 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.

Official Title
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EFFECT OF EXERCISE AND DIETARY WEIGHT LOSS ON SYMPTOMS AND SYSTEMIC INFLAMMATION IN OBESE ADULTS WITH PSORIATIC ARTHRITIS: RANDOMIZED CONTROLLED TRIAL

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Other: Diet
* Other: Exercise
* Other: Diet and Exercise
* Other: Healthy Lifestyle (Control) Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PsA patients with a body mass index (BMI) ≥30 Must satisfy the classification of psoriatic arthritis criteria Exclusion Criteria: Other inflammatory conditions

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diet<br>Low-fat diet | Other: Diet<br> <br> |
| Other: Exercise<br>3-day/week exercise programme | Other: Exercise<br> <br> |
| Other: Diet and exercise<br>healthy low fat diet and 3day/week exercise programme | Other: Diet and Exercise<br> <br> |
| Other: Healthy lifestyle (Control) group<br>Control group was provided with health education using videotaped presentation | Other: Healthy Lifestyle (Control) Group<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 response |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI score |  | 12 months | 
| DAS28-CRP response |  | 12 months | 
| physician global assessment (PGA) |  | 12 months | 
| patient global assessment (PGA) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic arthritis, inflammation, obesity, diet, exercise