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Clinical Trials/NCT02903992
NCT02903992
Completed
Not Applicable

SArcopenia Prevalence in Frail Older Adults: SAF Study

University Hospital, Toulouse1 site in 1 country225 target enrollmentMay 1, 2016
ConditionsAging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
University Hospital, Toulouse
Enrollment
225
Locations
1
Primary Endpoint
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
December 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • (SPPB) score(one day (participation of subject))
  • (IADL) score(one day (participation of subject))
  • (MMSE) score(one day (participation of subject))
  • (MNA) score(one day (participation of subject))

Study Sites (1)

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