SArcopenia Prevalence in Frail Older Adults. SAF Study

Aging Clinical Trial

— SAF  

Official title:

SArcopenia Prevalence in Frail Older Adults: SAF Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903992
• Other study ID #: RC31/15/7817
• Secondary ID: 2016-A00181-50
• Status: Completed
• Phase: N/A
• Start date: May 1, 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: December 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Sarcopenia

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
France	Toulouse University Hospital (CHU de Toulouse)	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry	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	(SPPB) score	Short Physical Performance Battery (SPPB) score	one day (participation of subject)
Secondary	(MMSE) score	Mini-Mental State Examination (MMSE) score	one day (participation of subject)
Secondary	(MNA) score	Mini Nutritional Assessment (MNA) score	one day (participation of subject)
Secondary	(IADL) score	Instrumental Activities of Daily Living (IADL) score	one day (participation of subject)