ObesityPREFISARNCT06299241
Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity
An observational study of Obesity and Sarcopenia, run by Istituto Auxologico Italiano at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Obesity, Sarcopenia
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 21 Apr 2023to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Adult, Older adult
Study population: Obese patients (BMI > 35), of both genders, aged > 60 years, hospitalized at San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy for a multidisciplinary 3-week body weight reduction program.
Who may be able to join
- 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
Who cannot join
- obese patients with BMI < 35
- age < 60 years
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto Auxologico Italiano, Site Piancavallo
Oggebbio, Verbania, 28824
About this study
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.
Read the 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.
- Conditions
- Obesity, Sarcopenia
- Keywords
- Aging, Obesity, Sarcopenia, Physical performance
- Medical subject headings
- Obesity, Sarcopenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat free mass
Measurement of body composition parameters with bioimpedance analysis (BIA) and DEXA
Measured: Baseline
Evaluation of lower limb muscle strength
Measurement with the stair climbing test
Measured: Baseline
Senior Fitness Test (SFT)
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.
Measured: Baseline
Physical performance test (PPT)
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).
Measured: Baseline
Fat mass
Measurement of body composition parameters with bioimpedance analysis (BIA) and DEXA;
Measured: Baseline
Secondary outcomes (2)
Questionnaire SF-12 (Short Form Health Survey)
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.
Measured: Baseline
Oswestry Disability Index questionnaire
A questionnaire elaborated to have information on how back problems, or leg problems, can influence physical abilities related to daily life.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start21 Apr 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299241
- Sponsor's protocol ID
- 01C313
- Acronym
- PREFISAR
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT06299241
- Acronym / sponsor ID
- PREFISAR / 01C313
- Conditions
- Obesity, Sarcopenia
- Keywords
- Aging, Obesity, Sarcopenia, Physical performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Obese patients (BMI > 35), of both genders, aged > 60 years, hospitalized at San Giuseppe Hospital, Istituto Auxologico Italiano, IRCCS, Piancavallo (VB), Italy for a multidisciplinary 3-week body weight reduction program.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- obese patients with BMI < 35
- age < 60 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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 mass
Time frame: Baseline
Measurement of body composition parameters with bioimpedance analysis (BIA) and DEXA;
2 secondary outcomes
Questionnaire SF-12 (Short Form Health Survey)
Time frame: Baseline
Oswestry Disability Index questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Sarcopenia, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat free mass (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.