NCT06299241

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

February 28, 2024

Last Update Submit

April 29, 2025

Conditions

Keywords

AgingObesitySarcopeniaPhysical performance

Outcome Measures

Primary Outcomes (5)

  • Fat free mass

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

    Baseline

  • Evaluation of lower limb muscle strength

    Measurement with the stair climbing test

    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.

    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).

    Baseline

  • Fat mass

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

    Baseline

Secondary Outcomes (2)

  • Questionnaire SF-12 (Short Form Health Survey)

    Baseline

  • Oswestry Disability Index questionnaire

    Baseline

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • obese patients with BMI \< 35
  • age \< 60 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

MeSH Terms

Conditions

ObesitySarcopenia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Study Design

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

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 7, 2024

Study Start

April 21, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

April 30, 2025

Record last verified: 2025-04

Locations