ObesityCAPFISOBEANZNCT07614464
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
An observational study of Obesity and Sarcopenic Obesity, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
Obesity is a significant health problem whose prevalence has tripled worldwide in the last fifty years, also involving older people. Older people present sarcopenia, characterized by the progressive loss of muscle mass and strength. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Sarcopenic Obesity
- What is being tested?
- Fitness tests and questionnaires
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Hospitalized obese elderly following a 3-week integrated metabolic rehabilitation program + Normal weight elderly attending correct lifestyle program in their home town
Who may be able to join
- Both sexes
- Body Mass Index > 35 kg/m2
- Age > 65 years
- Hospitalized for a 3-week integrated metabolic rehabilitation program
- Both sexes
- Body Mass Index 20-25 kg/m2
- Age > 65 years
- Attendance of healthy lifestyle program in their home town
Who cannot join
- Absence of signed informed consent
- Normal weight elderly:
- Absence of signed informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Auxologico Italiano IRCCS, Site Piancavallo
Oggebbio, 28824
Alessandro Sartorio, MD, +39-02619111 ext. 2624, sartorio@auxologico.it
About this study
Obesity is a significant health problem whose prevalence has tripled worldwide in the last fifty years, also involving older people. Older people present sarcopenia, characterized by the progressive loss of muscle mass and strength. Sarcopenia, accompanied by an increase in adipose tissue, causes a specific condition called sarcopenic obesity. The increase in adipose tissue and the decrease in muscle mass determines a reduction in strength and physical abilities necessary to perform everyday activities of daily living in obese older people.
To understand how the condition of excess adipose tissue influences the activities of daily living of older people with obesity, it is necessary to compare the physical abilities, body composition, and results of various motor skills with normal-weight subjects, corrected for sex and age.
- Conditions
- Obesity, Sarcopenic Obesity
- Being tested
- Fitness tests and questionnaires
- Keywords
- Ageing, Obesity, Physical performance, Visceral adiposity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness tests and questionnairesOther
Anthropometric measurements, physical fitness tests and daily life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Obese elderly | Obese men and women of 65 years and older Receives: Other: Fitness tests and questionnaires | |
| Normal weight elderly | Normal weight men and women of 65 years and older Receives: Other: Fitness tests and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat mass
Fat mass as assessed by bioelectrical impedance
Measured: Baseline
Lean mass
Lean mass as assessed by bioelectrical impedance
Measured: Baseline
Barthel Index
Level of independence in 10 basic daily activities (ADLs) Total score ranges from 0 to 100
Measured: Baseline
Handgrip test
Score in kilograms (kg) using a hand dynamometer
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614464
- Sponsor's protocol ID
- 01C514
- Acronym
- CAPFISOBEANZ
- Status last verified
- Nov 2026
- First submitted
- 22 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
- ClinicalTrials.gov ID
- NCT07614464
- Acronym / sponsor ID
- CAPFISOBEANZ / 01C514
- Conditions
- Obesity, Sarcopenic Obesity
- Keywords
- Ageing, Obesity, Physical performance, Visceral adiposity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 May 2026 (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.
Obesity is a significant health problem whose prevalence has tripled worldwide in the last fifty years, also involving older people. Older people present sarcopenia, characterized by the progressive loss of muscle mass and strength. Sarcopenia, accompanied by an increase in adipose tissue, causes a specific condition called sarcopenic obesity. The increase in adipose tissue and the decrease in muscle mass determines a reduction in strength and physical abilities necessary to perform everyday activities of daily living in obese older people.
To understand how the condition of excess adipose tissue influences the activities of daily living of older people with obesity, it is necessary to compare the physical abilities, body composition, and results of various motor skills with normal-weight subjects, corrected for sex and age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese elderly | – | Other: Fitness tests and questionnairesObese men and women of 65 years and older |
| Normal weight elderly | – | Other: Fitness tests and questionnairesNormal weight men and women of 65 years and older |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Hospitalized obese elderly following a 3-week integrated metabolic rehabilitation program + Normal weight elderly attending correct lifestyle program in their home town
Key inclusion criteria (8 listed)
- Both sexes
- Body Mass Index > 35 kg/m2
- Age > 65 years
- Hospitalized for a 3-week integrated metabolic rehabilitation program
- Both sexes
Key exclusion criteria (3 listed)
- Absence of signed informed consent
- Absence of signed informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness tests and questionnairesAnthropometric measurements, physical fitness tests and daily life questionnaires | Other | Normal weight elderly, Obese elderly |
Primary outcome
Fat mass
Time frame: Baseline
Fat mass as assessed by bioelectrical impedance
Lean mass
Time frame: Baseline
Lean mass as assessed by bioelectrical impedance
Barthel Index
Time frame: Baseline
Level of independence in 10 basic daily activities (ADLs) Total score ranges from 0 to 100
Handgrip test
Time frame: Baseline
Score in kilograms (kg) using a hand dynamometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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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.
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 Sarcopenic Obesity, 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 8 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Sartorio, MD (+3902619111 ext. 2426, sartorio@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat mass (time frame: Baseline). The study lists 4 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 6 Nov 2026.