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Clinical Trials/NCT06299241
NCT06299241
Completed
N/A

Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity

Istituto Auxologico Italiano1 site in 1 country80 target enrollmentApril 21, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Istituto Auxologico Italiano
Enrollment
80
Locations
1
Primary Endpoint
Physical performance test (PPT)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 21, 2023
End Date
October 31, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Physical performance test (PPT)

Time Frame: 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

Time Frame: Baseline

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

Evaluation of lower limb muscle strength

Time Frame: Baseline

Measurement with the stair climbing test

Senior Fitness Test (SFT)

Time Frame: 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

Time Frame: Baseline

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

Secondary Outcomes

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

Study Sites (1)

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