Clinical trial NCT02188641: Effect of Exercise and Diet on Psoriatic Arthritis
Official title: EFFECT OF EXERCISE AND DIETARY WEIGHT LOSS ON SYMPTOMS AND SYSTEMIC INFLAMMATION IN OBESE ADULTS WITH PSORIATIC ARTHRITIS: RANDOMIZED CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
inflammation
obesity
diet
exercise
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: ACR20 response
timeFrame: 12 months
Secondary outcomes:
measure: PASI score
timeFrame: 12 months
measure: DAS28-CRP response
timeFrame: 12 months
measure: physician global assessment (PGA)
timeFrame: 12 months
measure: patient global assessment (PGA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: University of Alexandria
Study officials:
affiliation: University of Alexandria
name: Anna Abou-Raya, MD
role: PRINCIPAL_INVESTIGATOR
References: