AgingSAFNCT02903992
SArcopenia Prevalence in Frail Older Adults. SAF Study
A study testing Dual-energy X-ray absorptiometry (DXA) in people with Aging, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Dual-energy X-ray absorptiometry (DXA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- Dual-energy X-ray absorptiometry (DXA)
- Keywords
- Frail Elderly, sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-energy X-ray absorptiometry (DXA)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.
| Study group | Role | What they receive |
|---|---|---|
| All patients recruited | Other | 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. Receives: Radiation: Dual-energy X-ray absorptiometry (DXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day (participation of subject)
Secondary outcomes (4)
(SPPB) score
Short Physical Performance Battery (SPPB) score
Measured: one day (participation of subject)
(MMSE) score
Mini-Mental State Examination (MMSE) score
Measured: one day (participation of subject)
(MNA) score
Mini Nutritional Assessment (MNA) score
Measured: one day (participation of subject)
(IADL) score
Instrumental Activities of Daily Living (IADL) score
Measured: one day (participation of subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start1 May 2016
- Primary completion31 Dec 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand FOUGERE, MD, Ph D, Principal investigator, oulouse University Hospital (CHU de Toulouse)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903992
- Sponsor's protocol ID
- RC31/15/7817
- Other IDs
- 2016-A00181-50
- Acronym
- SAF
- Status last verified
- Oct 2021
- First submitted
- 29 Jun 2016
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SArcopenia Prevalence in Frail Older Adults: SAF Study
- ClinicalTrials.gov ID
- NCT02903992
- Acronym / sponsor ID
- SAF / RC31/15/7817
- Conditions
- Aging
- Keywords
- Frail Elderly, sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients recruited | Other | Radiation: Dual-energy X-ray absorptiometry (DXA)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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | All patients recruited |
Primary outcome
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.
4 secondary outcomes
(SPPB) score
Time frame: one day (participation of subject)
(MMSE) score
Time frame: one day (participation of subject)
(MNA) score
Time frame: one day (participation of subject)
(IADL) score
Time frame: one day (participation of subject)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand FOUGERE, MD, Ph D principal investigator
oulouse University Hospital (CHU de Toulouse)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-energy X-ray absorptiometry (DXA) in people with Aging, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia Diagnostic with Dual-energy X-ray absorptiometry (time frame: one day (participation of subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.