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临床试验/NCT06299241
NCT06299241已完成不适用

Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity

Istituto Auxologico Italiano1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Physical performance test (PPT)

研究概览

简要总结

The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient.

详细描述

80 obese patients of both genders (BMI > 35), with an age > 60 years, hospitalized at the Hospital San Giuseppe, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB) are selected. For each patient, the following information are collected at the time of admission:

  • anthropometric parameters (height, weight, BMI, waist and hip circumference);
  • body composition (free fat mass, fat mass), measured with impedance (BIA) and DEXA;
  • hand strength measured with the hand grip test;
  • explosive strength of lower limbs, measured with the stair climbing test;
  • Senior Fitness Test (SFT), a battery of tests useful to estimate the fitness level in the elderly. SFT is a test that leads to measuring different physical parameters typical of daily activities: strength of upper and lower limbs, aerobic resistance, flexibility of lower and upper limbs, agility, and dynamic equilibrium. The measurements obtained make it possible to classify the skills as high function or low function.
  • Physical performance test (PPT), which evaluates 7 physical capabilities areas of the subject to perform actions during daily life. The cut-off to determine the motor limitation condition is a score of ≤ 20 (out of 28 points).
  • Questionnaire SF-12 (Short Form Health Survey), which leads to a multi-dimensional measuring of the life quality related to health. It is composed of 12 questions from which can be obtained two synthetic indices, one related to physical health and one related to mental health.
  • Oswestry Disability Index questionnaire, elaborated to have information on how back problems, or leg problems, can influence physical abilities related to daily life.

The presence of sarcopenia is identified based on the European Working Group on Sarcopenia in Older People (EWGSOP2) (Cruz-Jentoft AJ et al. 2019) definition. The physical performance parameters is evaluated according to the age, sex, obesity grade, and presence of sarcopenic obesity.

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
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • obese patients (BMI > 35),
  • both genders
  • age > 60 years
  • hospitalization at San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy for a multidisciplinary 3-week body weight reduction program

排除标准

  • obese patients with BMI < 35
  • age < 60 years

结局指标

主要结局

Physical performance test (PPT)

时间窗: Baseline

A test evaluating 7 physical capabilities areas of the subject to perform actions during daily life. The cut-off to determine the motor limitation condition is a score of ≤ 20 (out of 28 points).

Fat free mass

时间窗: Baseline

Measurement of body composition parameters with bioimpedance analysis (BIA) and DEXA

Evaluation of lower limb muscle strength

时间窗: Baseline

Measurement with the stair climbing test

Senior Fitness Test (SFT)

时间窗: Baseline

A battery of tests useful to estimate the fitness level of the elderly. This is a test that allows measuring different physical parameters typical of daily activities: strength of upper and lower limbs, aerobic resistance, flexibility of lower and upper limbs, agility, and dynamic equilibrium.

Fat mass

时间窗: Baseline

Measurement of body composition parameters with bioimpedance analysis (BIA) and DEXA;

次要结局

  • Questionnaire SF-12 (Short Form Health Survey)(Baseline)
  • Oswestry Disability Index questionnaire(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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