- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02903992
SArcopenia Prevalence in Frail Older Adults. SAF Study (SAF)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- Toulouse University Hospital (CHU de Toulouse)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Bertrand FOUGERE, MD, Ph D, oulouse University Hospital (CHU de Toulouse)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
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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