Effect of Exercise and Diet on Psoriatic Arthritis

• ClinicalTrials.gov Identifier: NCT02188641
• Recruitment Status: Completed
• First Posted: July 11, 2014
• Last Update Posted: July 11, 2014
• Sponsor: University of Alexandria
• Information provided by (Responsible Party): Anna Abou-Raya, University of Alexandria

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriatic Arthritis	Other: Diet; Other: Exercise; Other: Diet and Exercise; Other: Healthy Lifestyle (Control) Group	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: EFFECT OF EXERCISE AND DIETARY WEIGHT LOSS ON SYMPTOMS AND SYSTEMIC INFLAMMATION IN OBESE ADULTS WITH PSORIATIC ARTHRITIS: RANDOMIZED CONTROLLED TRIAL
• Study Start Date: June 2013
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. ACR20 response [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. PASI score [ Time Frame: 12 months ]
2. DAS28-CRP response [ Time Frame: 12 months ]
3. physician global assessment (PGA) [ Time Frame: 12 months ]
4. patient global assessment (PGA) [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Other inflammatory conditions

Contacts and Locations

Locations

Egypt

University of Alexandria

Alexandria, Egypt, 00203

Sponsors and Collaborators

University of Alexandria

Investigators

• Principal Investigator: Anna Abou-Raya, MD; University of Alexandria

More Information

• Responsible Party: Anna Abou-Raya, MD, University of Alexandria
• ClinicalTrials.gov Identifier: NCT02188641
• Other Study ID Numbers: alexmed12671300
• First Posted: July 11, 2014
• Last Update Posted: July 11, 2014
• Last Verified: July 2014

Keywords provided by Anna Abou-Raya, University of Alexandria:

Psoriatic arthritis; inflammation; obesity; diet; exercise

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases