The Effects of Weight Loss on Psoriatic Arthritis

• Sponsor: Hacettepe University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05393141
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 2.5
• Patients Per Site Per Month: 17.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis; Obesity	Behavioral: diet and biopsychosocial exercise intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Body Weight Management and Cognitive Exercise Therapy Approach on Psoriatic Arthritis Symptoms
• Anticipated Study Start Date: Jul 30, 2022
• Anticipated Primary Completion Date: Aug 15, 2022
• Anticipated Study Completion Date: Oct 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Weight Loss [At the end of 3 months]

   BMI (kilogram/metre2(kg/m2))

2. DAPSA score [At the end of 3 months]

   The score ranges from 0 to 50 points, with increased score reflect more discomfort

Secondary Outcome Measures

1. Quality of Life Score [At the end of 3 months]

   The score ranges from 0 to 100 points, with increased score reflecting improved quality of life

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• overweight/obese

• diagnosed with PSA

Exclusion Criteria

• pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sümeyra Öteleş	Ankara		Turkey	06100

Sponsors and Collaborators

• Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sumeyra Oteles, Clinical Researcher of the Hacettepe University, Hacettepe University
• ClinicalTrials.gov Identifier: NCT05393141
• Other Study ID Numbers: HU-SO-2022
• First Posted: May 26, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sumeyra Oteles, Clinical Researcher of the Hacettepe University, Hacettepe University: psoriatic arthritis; diet; biopsychosocial exercise
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic

Study Results

No Results Posted as of Aug 1, 2022