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临床试验/NCT05393141
NCT05393141已完成不适用

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

Hacettepe University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •overweight/obese
  • •diagnosed with PSA

排除标准

  • •pregnancy or lactation

研究组 & 干预措施

diet group

Experimental

weight loss diet intervention for 12 weeks

干预措施: diet and biopsychosocial exercise intervention (Behavioral)

diet+bety group

Experimental

weight loss diet intervention for 12 weeks and exercise-based biopsychosocial approach (Cognitive Exercise Therapy Approach-BETY) intervention for 12 weeks

干预措施: diet and biopsychosocial exercise intervention (Behavioral)

control group

No Intervention

no intervention, control

结局指标

主要结局

Weight Loss

时间窗: At the end of 3 months

BMI (kilogram/metre2(kg/m2))

DAPSA score

时间窗: At the end of 3 months

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

次要结局

  • Quality of Life Score(At the end of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sumeyra Oteles

Clinical Researcher of the Hacettepe University

Hacettepe University

研究点 (1)

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