NCT07614464

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
May 2025Dec 2026

Study Start

First participant enrolled

May 29, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 29, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 22, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

AgeingObesityPhysical performanceVisceral adiposity

Outcome Measures

Primary Outcomes (4)

  • Fat mass

    Fat mass as assessed by bioelectrical impedance

    Baseline

  • Lean mass

    Lean mass as assessed by bioelectrical impedance

    Baseline

  • Barthel Index

    Level of independence in 10 basic daily activities (ADLs) Total score ranges from 0 to 100

    Baseline

  • Handgrip test

    Score in kilograms (kg) using a hand dynamometer

    Baseline

Study Arms (2)

Obese elderly

Obese men and women of 65 years and older

Other: Fitness tests and questionnaires

Normal weight elderly

Normal weight men and women of 65 years and older

Other: Fitness tests and questionnaires

Interventions

Anthropometric measurements, physical fitness tests and daily life questionnaires

Normal weight elderlyObese elderly

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized obese elderly following a 3-week integrated metabolic rehabilitation program \+ Normal weight elderly attending correct lifestyle program in their home town

You may qualify if:

  • Both sexes
  • Body Mass Index \> 35 kg/m2
  • Age \> 65 years
  • Hospitalized for a 3-week integrated metabolic rehabilitation program

You may not qualify if:

  • Absence of signed informed consent
  • Normal weight elderly:
  • Both sexes
  • Body Mass Index 20-25 kg/m2
  • Age \> 65 years
  • Attendance of healthy lifestyle program in their home town
  • Absence of signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, 28824, Italy

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Alessandro Sartorio, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2026

First Posted

May 29, 2026

Study Start

May 29, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations