Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06299241 |
| Other study ID # |
01C313 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 21, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Istituto Auxologico Italiano |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
