Effect of Exercise and Diet on Psoriatic Arthritis

Not Applicable

Completed

• Conditions: Psoriatic Arthritis
• Interventions: Other: Diet and Exercise; Other: Diet; Other: Exercise; Other: Healthy Lifestyle (Control) Group

• Registration Number: NCT02188641
• Lead Sponsor: University of Alexandria

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Study First Posted: 2014-07-11
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• PsA patients with a body mass index (BMI) ≥30
• Must satisfy the classification of psoriatic arthritis criteria

Exclusion Criteria

• Other inflammatory conditions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet and exercise	Diet and Exercise	healthy low fat diet and 3day/week exercise programme
Diet	Diet	Low-fat diet
Exercise	Exercise	3-day/week exercise programme
Healthy lifestyle (Control) group	Healthy Lifestyle (Control) Group	Control group was provided with health education using videotaped presentation

Primary Outcome Measures

Name	Time	Method
ACR20 response	12 months

Secondary Outcome Measures

Name	Time	Method
PASI score	12 months
DAS28-CRP response	12 months
physician global assessment (PGA)	12 months
patient global assessment (PGA)	12 months

Trial Locations

Locations (1)

University of Alexandria; 🇪🇬 Alexandria, Egypt