SArcopenia Prevalence in Frail Older Adults. SAF Study (SAF)
Primary Purpose
Aging
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dual-energy X-ray absorptiometry (DXA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Aging focused on measuring Frail Elderly, sarcopenia
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.
Sites / Locations
- Toulouse University Hospital (CHU de Toulouse)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients recruited
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
(SPPB) score
Short Physical Performance Battery (SPPB) score
(MMSE) score
Mini-Mental State Examination (MMSE) score
(MNA) score
Mini Nutritional Assessment (MNA) score
(IADL) score
Instrumental Activities of Daily Living (IADL) score
Full Information
NCT ID
NCT02903992
First Posted
June 29, 2016
Last Updated
October 22, 2021
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02903992
Brief Title
SArcopenia Prevalence in Frail Older Adults. SAF Study
Acronym
SAF
Official Title
SArcopenia Prevalence in Frail Older Adults: SAF Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging
Keywords
Frail Elderly, sarcopenia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients recruited
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Dual-energy X-ray absorptiometry (DXA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry
Description
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.
Time Frame
one day (participation of subject)
Secondary Outcome Measure Information:
Title
(SPPB) score
Description
Short Physical Performance Battery (SPPB) score
Time Frame
one day (participation of subject)
Title
(MMSE) score
Description
Mini-Mental State Examination (MMSE) score
Time Frame
one day (participation of subject)
Title
(MNA) score
Description
Mini Nutritional Assessment (MNA) score
Time Frame
one day (participation of subject)
Title
(IADL) score
Description
Instrumental Activities of Daily Living (IADL) score
Time Frame
one day (participation of subject)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand FOUGERE, MD, Ph D
Organizational Affiliation
oulouse University Hospital (CHU de Toulouse)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital (CHU de Toulouse)
City
Toulouse
ZIP/Postal Code
31059
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SArcopenia Prevalence in Frail Older Adults. SAF Study
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