- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07614464
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults (CAPFISOBEANZ)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alessandro Sartorio, MD
- Phone Number: 2426 +3902619111
- Email: sartorio@auxologico.it
Study Contact Backup
- Name: Luca Grappiolo, Dr
- Phone Number: 2894 +3902619111
- Email: luca.grappiolo@auxologico.it
Study Locations
-
-
-
Oggebbio, Italy, 28824
- Recruiting
- Istituto Auxologico Italiano IRCCS, Site Piancavallo
-
Contact:
- Alessandro Sartorio, MD
- Phone Number: 2624 +39-02619111
- Email: sartorio@auxologico.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Hospitalized obese elderly following a 3-week integrated metabolic rehabilitation program
+ Normal weight elderly attending correct lifestyle program in their home town
Description
Obese elderly:
Inclusion Criteria:
- Both sexes
- Body Mass Index > 35 kg/m2
- Age > 65 years
- Hospitalized for a 3-week integrated metabolic rehabilitation program
Exclusion Criteria:
- Absence of signed informed consent
Normal weight elderly:
Inclusion Criteria:
- Both sexes
- Body Mass Index 20-25 kg/m2
- Age > 65 years
- Attendance of healthy lifestyle program in their home town
Exclusion Criteria:
- Absence of signed informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Obese elderly
Obese men and women of 65 years and older
|
Anthropometric measurements, physical fitness tests and daily life questionnaires
|
|
Normal weight elderly
Normal weight men and women of 65 years and older
|
Anthropometric measurements, physical fitness tests and daily life questionnaires
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fat mass
Time Frame: Baseline
|
Fat mass as assessed by bioelectrical impedance
|
Baseline
|
|
Lean mass
Time Frame: Baseline
|
Lean mass as assessed by bioelectrical impedance
|
Baseline
|
|
Barthel Index
Time Frame: Baseline
|
Level of independence in 10 basic daily activities (ADLs) Total score ranges from 0 to 100
|
Baseline
|
|
Handgrip test
Time Frame: Baseline
|
Score in kilograms (kg) using a hand dynamometer
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nutrition Disorders
- Overnutrition
- Body Weight
- Overweight
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 01C514
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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