SArcopenia Prevalence in Frail Older Adults. SAF Study (SAF)

October 22, 2021 updated by: University Hospital, Toulouse

SArcopenia Prevalence in Frail Older Adults: SAF Study

The age-associated loss of lean mass is a defining parameter of sarcopenia and may lead to various negative health outcomes such as impairment of physical performance and disability. Furthermore sarcopenia is considered to be one of the main factors in the pathogenesis of the frailty syndrome. However, for clinical use and for treatment and prevention strategies, reliable diagnostic criteria and cutpoints based on clinically relevant thresholds are indispensable.

This topic has recently been addressed by the Foundation for the National Institutes of Health Sarcopenia Project which identified cutpoints for appendicular lean mass (ALM) below which older adults had a higher likelihood of clinically relevant weakness reflected by low grip strength. Moreover, a low ALM-to-body mass index (BMI) ratio (<0.789 men and <0.512 women) was found to be associated with increased likelihood for mobility impairment.

In this context, the aim of this study is to study the prevalence of sarcopenia in a sample of community-dwelling frail and pre-frail older adults.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

      • Toulouse, France, 31059
        • Toulouse University Hospital (CHU de Toulouse)

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

Description

Inclusion Criteria:

  • Aged 70 years and over,
  • Living independently (ADL score ≥ 5/6),
  • Fail or pre-frail according to Fried criteria,
  • Informed written consent,
  • Subjects affiliated to a social security.

Exclusion Criteria:

  • Robusts patients (no Fried criteria),
  • Other disorders that could interfere with the interpretation of the study (like visual or hearing impairments),
  • Subjects under justice protection,
  • Participation in another study at the same time.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All patients recruited
All patients who are enrolled in study with at least one Fried criteria will have a Dual-energy X-ray absorptiometry (DXA) to measure lean muscle mass adjusted for body mass index. As part of the usual care in the Frailty Clinic patients will also have a clinical examination, a standard biological sample (requiring 15 ml of blood); an evaluation of the cognitive and functional performances, of their medico-economic situation and lifestyle.
Patients with at least one Fried criteria will have a Dual-energy X-ray absorptiometry (DXA) to measure lean muscle mass adjusted for body mass index. As part of the usual care in the Frailty Clinic patients will also have a clinical examination, a standard biological sample (requiring 15 ml of blood); an evaluation of the cognitive and functional performances, of their medico-economic situation and lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry
Time Frame: one day (participation of subject)
The primary outcome of SAF study is to assess the prevalence of sarcopenia in frail and pre-frail older adults. The primary endpoint is the sarcopenia diagnostic. In patients with at least one Fried criteria, we would like to detect the number of patient with low lean muscle mass adjusted for body mass index <0.789 for men and <0.512 for women.
one day (participation of subject)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(SPPB) score
Time Frame: one day (participation of subject)
Short Physical Performance Battery (SPPB) score
one day (participation of subject)
(MMSE) score
Time Frame: one day (participation of subject)
Mini-Mental State Examination (MMSE) score
one day (participation of subject)
(MNA) score
Time Frame: one day (participation of subject)
Mini Nutritional Assessment (MNA) score
one day (participation of subject)
(IADL) score
Time Frame: one day (participation of subject)
Instrumental Activities of Daily Living (IADL) score
one day (participation of subject)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Bertrand FOUGERE, MD, Ph D, oulouse University Hospital (CHU de Toulouse)

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 (Actual)

May 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 16, 2016

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • RC31/15/7817
  • 2016-A00181-50 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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