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NCT04464278 Clinical Trial

Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization

Body Weight Changes Clinical Trial

— VALCOR  

Official title:
Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04464278
Other study ID # APHP200265
Secondary ID IDRCB 2019-A0328
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2020
Est. completion date October 2023

Study information
Verified date July 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Christine FORASASSI, MD
Phone 01 40 19 34 14
Email christine.forasassi@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

Description:

Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.

There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 360
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Patient =70 years old

- Hospitalized in SSR for less than 7 days

- No patient opposition

Exclusion Criteria:

- patient with a pacemaker

- lake of nutritional assessment on admission

- lake of assessment of autonomy at admission

- Patient under guardianship or curatorship

- Patient participating in another clinical research

- Patient for whom a short stay (<21 days) is planned in SSR

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris INSERM UMR S 1136

Outcome
Type Measure Description Time frame Safety issue
Primary The prognosis value of variation of weight on mortality Determination of variation of weight between D0 and D21 after inclusion 3 months
Primary Mortality rate Monitoring of survival at 3 months after inclusion 3 months
Secondary The pprognosis value of variation of weight on unscheduled readmission in SSR Determination of variation of weight between D0 and D21 after inclusion Between D0 and D21
Secondary Unscheduled readmission in SSR Monitoring of unscheduled readmission during 15 days after the end of hospitalization during 15 days after the end of hospitalization
Secondary Lean mass pronostic value Determine the prognosis value of variation in lean mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization 3 months after the inclusion
Secondary In fat mass pronostic value Determine the prognosis value of variation in fat mass on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization 3 months after the inclusion
Secondary fat / lean mass ratio Determine the prognosis value of fat / lean mass ratio on mortality and unscheduled readmission in SSR within 15 days of end of hospitalization 3 months after the inclusion
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