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Effect of Exercise and Diet on Psoriatic Arthritis

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


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.

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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


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



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188641


Locations
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Egypt
University of Alexandria
Alexandria, Egypt, 00203
Sponsors and Collaborators
University of Alexandria
Investigators
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Principal Investigator: Anna Abou-Raya, MD University of Alexandria
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Responsible Party: Anna Abou-Raya, MD, University of Alexandria
ClinicalTrials.gov Identifier: NCT02188641    
Other Study ID Numbers: alexmed12671300
First Posted: July 11, 2014    Key Record Dates
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:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases