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Completed

NCT Number: NCT06299241

Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fat free mass

    Time frame: Baseline

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

  2. Evaluation of lower limb muscle strength

    Time frame: Baseline

    Measurement with the stair climbing test

  3. 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.

  4. 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).

  5. Fat mass

    Time frame: Baseline

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

Secondary outcomes

  1. Questionnaire SF-12 (Short Form Health Survey)

    Time frame: Baseline

    A questionnaire allowing a multi-dimensional measurement of quality of life related to health. It is composed of 12 questions from which it is possible obtaining two synthetic indexes, one related to physical health and the other one related to mental health.

  2. Oswestry Disability Index questionnaire

    Time frame: Baseline

    A questionnaire elaborated to have information on how back problems, or leg problems, can influence physical abilities related to daily life.

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: PREFISAR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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