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SArcopenia Prevalence in Frail Older Adults. SAF Study

NCT ID: NCT02903992

Last Updated: 2021-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aging

Keywords

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Frail Elderly sarcopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Dual-energy X-ray absorptiometry (DXA)

Intervention Type RADIATION

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.

Interventions

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Dual-energy X-ray absorptiometry (DXA)

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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand FOUGERE, MD, Ph D

Role: PRINCIPAL_INVESTIGATOR

oulouse University Hospital (CHU de Toulouse)

Locations

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Toulouse University Hospital (CHU de Toulouse)

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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2016-A00181-50

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/15/7817

Identifier Type: -

Identifier Source: org_study_id