The Effects of Weight Loss on Psoriatic Arthritis

December 4, 2022 updated by: Sumeyra Oteles, Hacettepe University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Sümeyra Öteleş

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • overweight/obese
  • diagnosed with PSA

Exclusion Criteria

  • pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diet group
weight loss diet intervention for 12 weeks
Behavioral: diet and biopsychosocial exercise intervention
dietary intervention: biopsychosocial exercise intervention:
Experimental: diet+bety group
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
dietary intervention: biopsychosocial exercise intervention:
No Intervention: control group
no intervention, control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: At the end of 3 months
BMI (kilogram/metre2(kg/m2))
At the end of 3 months
DAPSA score
Time Frame: At the end of 3 months
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
Time Frame: At the end of 3 months
The score ranges from 0 to 100 points, with increased score reflecting improved quality of life
At the end of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 4, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HU-SO-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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