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Effect of Exercise and Diet on Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diet
Exercise
Diet and Exercise
Healthy Lifestyle (Control) Group
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic arthritis, inflammation, obesity, diet, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Other inflammatory conditions

Sites / Locations

  • University of Alexandria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Diet

Exercise

Diet and exercise

Healthy lifestyle (Control) group

Arm Description

Low-fat diet

3-day/week exercise programme

healthy low fat diet and 3day/week exercise programme

Control group was provided with health education using videotaped presentation

Outcomes

Primary Outcome Measures

ACR20 response

Secondary Outcome Measures

PASI score
DAS28-CRP response
physician global assessment (PGA)
patient global assessment (PGA)

Full Information

First Posted
July 4, 2014
Last Updated
July 9, 2014
Sponsor
University of Alexandria
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1. Study Identification

Unique Protocol Identification Number
NCT02188641
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic arthritis, inflammation, obesity, diet, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diet
Arm Type
Other
Arm Description
Low-fat diet
Arm Title
Exercise
Arm Type
Other
Arm Description
3-day/week exercise programme
Arm Title
Diet and exercise
Arm Type
Other
Arm Description
healthy low fat diet and 3day/week exercise programme
Arm Title
Healthy lifestyle (Control) group
Arm Type
Other
Arm Description
Control group was provided with health education using videotaped presentation
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Type
Other
Intervention Name(s)
Diet and Exercise
Intervention Type
Other
Intervention Name(s)
Healthy Lifestyle (Control) Group
Primary Outcome Measure Information:
Title
ACR20 response
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PASI score
Time Frame
12 months
Title
DAS28-CRP response
Time Frame
12 months
Title
physician global assessment (PGA)
Time Frame
12 months
Title
patient global assessment (PGA)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Abou-Raya, MD
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alexandria
City
Alexandria
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Effect of Exercise and Diet on Psoriatic Arthritis

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