The Effects of Weight Loss on Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
Psoriatic arthritis (PsA) is an inflammatory arthritis associated with psoriasis. Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. This study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach (BETY-Bilişsel Egzersiz Terapi Yöntemi) interventions on symptoms. Accordingly, 45 overweight/obese subjects with PSA aged 20-65 years will divide into diet, diet+bety, and control groups. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at the end of the study.

Detailed Description
-----------------
Although the underlying cause of PSA is unclear, increased body weight is known to increase the disease symptoms. The present study aims to determine the effects of dietary and Cognitive Exercise Therapy Approach interventions on symptoms. Fourt-five overweight/obese subjects with PSA aged 20-65 years will divide into diet (n=15), diet+bety (n=15), and control (n=15) groups. Individually diet programs will be applied according to the metabolic, biochemical, and physical activity status of the subjects prepared by a registered dietitian. BETY exercise training will be given by a registered physiotherapist. The subjects will be followed for 12 weeks. Dietary, laboratory and anthropometric records, Short Form Health Survey, DAPSA (Disease Activity in Psoriatic Arthritis), HAQ (Health Assesment Questionnaire) of all subjects will compare at the baseline and at study completion.

Official Title
-----------------
The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms

Conditions
-----------------
Psoriatic Arthritis, Obesity

Intervention / Treatment
-----------------
* Behavioral: diet and biopsychosocial exercise intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: overweight/obese diagnosed with PSA Exclusion Criteria pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet group<br>weight loss diet intervention for 12 weeks | Behavioral: diet and biopsychosocial exercise intervention<br>* dietary intervention: biopsychosocial exercise intervention:<br>|
| Experimental: diet+bety group<br>weight loss diet intervention for 12 weeks and exercise-based biopsychosocial approach (Cognitive Exercise Therapy Approach-BETY) intervention for 12 weeks | Behavioral: diet and biopsychosocial exercise intervention<br>* dietary intervention: biopsychosocial exercise intervention:<br>|
| No Intervention: control group<br>no intervention, control | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss | BMI (kilogram/metre2(kg/m2)) | At the end of 3 months | 
| DAPSA score | The score ranges from 0 to 50 points, with increased score reflect more discomfort | At the end of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score | The score ranges from 0 to 100 points, with increased score reflecting improved quality of life | At the end of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriatic arthritis, diet, biopsychosocial exercise