The Effects of Nutritional Status and Habits on Disease Activity, Quality of Life and Functional Status of Patients in Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- A questionnaire form
研究概览
简要总结
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease.
RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity status and physical functional status of the patients included in the study.
详细描述
Rheumatoid arthritis (RA) is a chronic, autoimmune, systemic, inflammatory disease affecting 0.5-1.0% of the population. RA is a chronic inflammatory disease in which many patients cannot achieve remission despite current pharmacological treatments. Chronic inflammation in RA causes an increase in metabolic index and nutritional requirements. In recent studies, it is mentioned that diet regimens and foods consumed in nutrition affect inflammation.
The aim of this study is to evaluate the nutritional status and habits of patients with RA and to examine their effects on disease activity level, quality of life and functional status.
This study will be conducted with 100 patients diagnosed with RA in Balıkesir University, Health Practice and Research Hospital, Department of Physical Medicine and Rehabilitation outpatient clinic.
Patients between the ages of 18-75, diagnosed with RA according to the ACR 2010 diagnostic criteria, with a disease duration of 2 or more, using less than 10 mg of prednisolone per day, will be included in the study. Patients with a duration of ≤2 years after the diagnosis of RA, a change in the use of DMARDs and/or biological agents in their medical treatment for the last 8 weeks, using prednisolone more than 10 mg daily, malignancy, pregnant, lactating, and those who cannot understand the information in the questionnaire was not included in the study.
A questionnaire form will be applied to collect data on demographic information, disease activity, nutritional status and habits, physical activity and physical functional status of the patients included in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 18-75,
- •Diagnosed with RA according to ACR 2010 diagnostic criteria,
- •RA disease duration at least ≥2 years
排除标准
- •During the lactation period,
- •Malignancy
- •Using more than 10 mg of prednisolone per day,
- •The period after the diagnosis of Ra is ≤2 years,
- •Changes in medical treatment, DMARD and/or biological agent use in the last 8 weeks,
- •Patients who cannot understand the information in the questionnaires
结局指标
主要结局
A questionnaire form
时间窗: Through study completion, an average of 4 month
A questionnaire form to evaluate the demographic information
Functional status of the patients.
时间窗: Through study completion, an average of 4 month
HAQ (Health Assessment Questionnaire)
Disease activity of the patients
时间窗: Through study completion, an average of 4 month
Simple Disease Activity Index (SDAI)
Nutritional status and habits;
时间窗: Through study completion, an average of 4 month
* Nutrient consumption frequencies * 24-hour retrospective food consumption record
次要结局
未报告次要终点
研究者
Bilal Uysal
Principal Investigator
Balikesir University
