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临床试验/NCT06563011
NCT06563011已完成不适用

The Assessment of Nutritional Status of Patients With IPF and The Effectiveness of Nutritional Support

İrem Çağla Özel2 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2023年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2

研究概览

简要总结

The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated.

A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, hand dynamometer, pulmonary function, and food frequency. Also quality of life were assessed by SGRQ. Tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

详细描述

Idiopathic pulmonary fibrosis (IPF) is an irreversible interstitial lung disease of unknown etiology, characterized by progressive loss of lung function. IPF is a disease of advanced age. Preliminary studies of IPF indicate that nutritional status may affect quality of life and prognosis, but the clinical significance of nutritional status has not been investigated. Weight loss is recognized as a common complication of IPF. There is no study that comprehensively evaluates the nutritional status of IPF patients in Turkey. The aim of this study is to comprehensively evaluate the nutritional status of IPF patients and to evaluate the effectiveness of 3-month dietary counselling. In this study, the nutritional status of IPF patients followed in Atatürk Sanatorium Training and Research Hospital were comprehensively evaluated. A comprehensive assessment were performed, including nutritional status, anthropometric measurements, body composition, dynamometer, pulmonary function, and several questionnaires. so quality of life were assessed by SGRQ. All measurements were taken at the baseline. Then, tailored dietary counselling were given to the patients and, patients were assessed at the end of the 3-month follow-up period in terms of same parameters.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
60 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with IPF

排除标准

  • Not giving written consent

结局指标

主要结局

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function-2

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in DLCO values at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Body Composition

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in body composition measured by BIA at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Energy Intake

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in energy intake (kcal/day) at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on BMI

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in BMI (kg/m2) at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Pulmonary Function

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in FVC values at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on Dietary Intake

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in carbohydrate, protein and fat intake (kcal/day) at 12 weeks were assessed.

The Effectiveness of Tailored Dietary Counselling in Patients with IPF on HRQL

时间窗: 12 weeks

The effect of dietary counselling on change from baseline in St. George Respiratory Questionnaire (SGRQ) score at 12 weeks were assessed. Scores range from 0-100. While score of zero indicates normal, and a score of 100 indicates impaired quality of life.

次要结局

未报告次要终点

研究者

发起方
İrem Çağla Özel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

İrem Çağla Özel

Principal Investigator

Ankara University

研究点 (2)

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