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临床试验/NCT05472480
NCT05472480Unknown不适用

Association Between Anthropometric and Psychosocial Measurements in Vascular Disease

University of Catanzaro1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Analysis of BMI

研究概览

简要总结

This experimental study is to verify a possible correlation between vascular disease, and anthropometric, and psychosocial measurements.

Consecutive patients with vascular diseases (Chronic Venous Disease, Carotid Stenosis, Abdominal Aortic Aneurysm, Peripheral Artery Disease) will be referred to Vascular Surgery Units of two hospitals linked to Interuniversity Center of Phlebolymphology (CIFL) International Research and Educational Program in Clinical and Experimental Biotechnology (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) to be evaluated.

Since it is necessary to study the anthropometric measures and the psychosocial aspects, different types of measurements will be carried out in order to correlate them with the aforementioned vascular disease.

详细描述

This is a cross sectional study with the aim analyze the association between the anthropometric and psychosocial measures in the following vascular disease: Chronic Venous Disease (CVD), Carotid Stenosis (CS) , Abdominal Aortic Aneurysm (AAA) , Peripheral Artery Disease (PAD).

Consecutive patients with vascular diseases (CVD, CS, AAA, PAD) referred to Vascular Surgery Units of two hospitals (Mater Domini University Hospital of Catanzaro and the Federico II University Hospital of Naples) will be evaluated.

Different types of measurements will be evaluated: body mass index (BMI), weight, height, waist circumference, waist / hip ratio (WHR), waist / stature (WSR) and the ABSI "a body" score shape index ". To complete the study, the personal experiences of the patients will be analyzed through the administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

The data will be extrapolated from a prospective analysis on patients, by inserting in a Microsoft Excel database: demographic characteristics (age, sex); anthropometric parameters (height, weight, BMI, waist circumference WHR WSR ABSI); comorbidities, with particular reference to Diabetes mellitus, Dyslipidemia, Hypertension, CRI, coronary heart disease; smoking as a risk factor; the questionnaire for psychosocial aspects (BIDQ) on cumulative score (1-15); the vascular disease under examination. Population variables (age) and continuous outcomes (weight, age, BMI, waist circumference, WHR, WSR, ABSI, BIDQ) will be analyzed by Kruskal-Wallis test, while categorical variables (males, smokers, hypertension, diabetes, insulin-dependent diabetes, dyslipidemia, CAD, renal insufficiency) with Pearson's Chi-square test. The statistically significant outcomes will be subjected to sub-analysis with t-test, to identify the comparisons responsible for statistical significance.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • age >18 years, both genders, being a patient with one type of vascular disease at the time of the study.

排除标准

  • presence of more than one contemporary vascular disease at the time of the study, to avoid overlapping of concomitant vascular disease.
  • presence of any illiteracy, or psychiatric issues that may impair understanding or self-administration of the questionnaire.
  • malignancies.

结局指标

主要结局

Analysis of BMI

时间窗: 32 months

This measurement (reported in kg/m\^2) will be related to the presence of vascular disease

Analysis of waist circumference

时间窗: 32 months

This measurement (reported in cm) will be related to the presence of vascular disease

Analysis of ABSI "a body" score shape index

时间窗: 32 months

This index (range: from "Less than -0.868" to "Greater than +0.798") will be related to the presence of vascular disease

Analysis of waist / hip ratio (WHR)

时间窗: 32 months

This ratio will be related to the presence of vascular disease

Analysis of waist / stature (WSR)

时间窗: 32 months

This ratio will be related to the presence of vascular disease

Administration of a psycho-social questionnaire, Body Image Disturbance Questionnaire (BIDQ).

时间窗: 32 months

The BIDQ comprises seven items. Items 1-2 assess appearance concern and preoccupation, while item 3 measures perceived distress, and items 4-7 investigate functional impairment and avoidance

次要结局

未报告次要终点

研究者

发起方
University of Catanzaro
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Raffaele Serra, MD, Ph.D.

Associate Professor of Vascular Surgery

University of Catanzaro

研究点 (1)

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