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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04464278
Collaborator
INSERM UMR S 1136 (Other)
360
Enrollment
39
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    360 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Predictive Value of Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization (Suite Care and Rehabilitation)
    Anticipated Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Case group: weight loss ≥ 5%
    Control group: weight loss ≤ 5%

    Outcome Measures

    Primary Outcome Measures

    1. The prognosis value of variation of weight on mortality [3 months]

      Determination of variation of weight between D0 and D21 after inclusion

    2. Mortality rate [3 months]

      Monitoring of survival at 3 months after inclusion

    Secondary Outcome Measures

    1. The pprognosis value of variation of weight on unscheduled readmission in SSR [Between D0 and D21]

      Determination of variation of weight between D0 and D21 after inclusion

    2. Unscheduled readmission in SSR [during 15 days after the end of hospitalization]

      Monitoring of unscheduled readmission during 15 days after the end of hospitalization

    3. Lean mass pronostic value [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

    4. In fat mass pronostic value [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

    5. fat / lean mass ratio [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    70 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris
    • INSERM UMR S 1136

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT04464278
    Other Study ID Numbers:
    • APHP200265
    • IDRCB 2019-A03287-50
    First Posted:
    Jul 9, 2020
    Last Update Posted:
    Jul 9, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Geriatric
    Suite Care and Rehabilitation
    Body composition
    Additional relevant MeSH terms:
    Body Weight
    Body Weight Changes

    Study Results

    No Results Posted as of Jul 9, 2020