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

July 8, 2020 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case group: weight loss ≥ 5%
Control group: weight loss ≤ 5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prognosis value of variation of weight on mortality
Time Frame: 3 months
Determination of variation of weight between D0 and D21 after inclusion
3 months
Mortality rate
Time Frame: 3 months
Monitoring of survival at 3 months after inclusion
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The pprognosis value of variation of weight on unscheduled readmission in SSR
Time Frame: Between D0 and D21
Determination of variation of weight between D0 and D21 after inclusion
Between D0 and D21
Unscheduled readmission in SSR
Time Frame: during 15 days after the end of hospitalization
Monitoring of unscheduled readmission during 15 days after the end of hospitalization
during 15 days after the end of hospitalization
Lean mass pronostic value
Time Frame: 3 months after the inclusion
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
In fat mass pronostic value
Time Frame: 3 months after the inclusion
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
fat / lean mass ratio
Time Frame: 3 months after the inclusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

INSERM UMR S 1136

Investigators

  • Principal Investigator: Christine FORASASSI, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

June 8, 2020

First Submitted That Met QC Criteria

July 8, 2020

First Posted (Actual)

July 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200265
  • IDRCB 2019-A03287-50 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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