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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05393141
Other study ID # HU-SO-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2022
Est. completion date October 15, 2022

Study information

Verified date December 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - overweight/obese - diagnosed with PSA Exclusion Criteria - pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
diet and biopsychosocial exercise intervention
dietary intervention: biopsychosocial exercise intervention:

Locations

Country Name City State
Turkey Sümeyra Öteles Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Loss BMI (kilogram/metre2(kg/m2)) At the end of 3 months
Primary DAPSA score The score ranges from 0 to 50 points, with increased score reflect more discomfort At the end of 3 months
Secondary 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
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