SarcopeniaSARA-OBSNCT03021798
An OBServational Clinical Trial (SARA-OBS) in Sarcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over
An observational study of Sarcopenia and Gait Disorders in Old Age, run by Biophytis at 7 sites in 4 countries.
Trial summary
The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US. Read more about this study
- Who is it for?
- Ages 65 to 95 years
- Conditions the study is for
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- What is being tested?
- No Drug and no aspecific intervention
- How many people
- 218 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 8 Feb 2017to 30 Jun 2020
- Phase
- Observational
- 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 65 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Study population: 300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability
Who may be able to join
- Men and women aged ≥ 65 years and living in the community, reporting loss of physical function
- Short Physical Performance Battery (SPPB) score ≤ 8
- ALM/BMI < 0.789 in men and 0.512 in women, by DXA scan
Who cannot join
- Unable or unwilling to provide informed consent
- Unable to understand and perform the functional tests, as judged by the Investigator
- Current treatment with anabolic drugs, i.e. testosterone
- Clinical conditions:
- Current diagnosis major psychiatric disorders.
- Alcohol abuse or dependence
Show all 18Show fewer
- Severe arthritis
- Cancer requiring active treatment
- Lung disease requiring regular use of supplemental oxygen
- Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents
- Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
- Parkinson's disease or other progressive neurological disorder
- Renal disease requiring dialysis
- Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline the 6MWT, or the 400-meter walk test
- Current physical/rehabilitation therapy
- Current enrolment in another clinical trial
- Concomitant condition implying life expectancy ≤ 6 months
- Any other condition precluding the regular participation to the clinical trial, as judged by the Investigator.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
Jean Mayer USDA Human Nutrition research Center on Aging Tufts University
Boston, Massachusetts, 02111
Institut On Aging
Gainesville, Florida, 32611
Columbia University New York
New York, New York, 10027
France2 sites
Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet
Pierre-Bénite, 69495
Gérontopole Toulouse
Toulouse
About this study
Official title: Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)
The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
Participants aged ≥ 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test and the 400-metre walking test will be administered at the main visits. Patient Reported Outcomes (PROs) will be completed by the patients at the same visits.
Read the detailed description
The SARA-OBS is a phase 2 clinical trial, with no investigational product and no therapeutic intervention. It will be conducted in three European countries, Belgium, France and Italy, and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
The general objective is to characterise sarcopenia including "sarcopenic obesity" in a population of older persons living in the community and at risk of mobility disability; evaluate their physical performance and body composition in view of the design of a phase 2 clinical study on the efficacy and safety of BIO101 on the prevention of mobility disability in the at-risk community dwelling older adults (≥65 years) reporting loss of physical function.
The primary objective characterise sarcopenia including sarcopenic obesity, in older persons at risk of mobility disability. Sarcopenia will be defined according to the criteria of the Foundation of NIH; the risk of mobility disability will be operationalised by the Short Physical Performance Battery (SPPB). For this purpose, the 6-minute walking distance and the 400-meter walking test will be evaluated at 6-month intervals, in the absence of any therapeutic intervention. The incident rate of change will be estimated on the sample and pre-specified subgroups (e.g. gender, SPPB baseline score, etc.).
Two important Secondary Objectives are also included :
- To evaluate muscle strength (handgrip/knee extension) and stair power climbing test
- To evaluate self-administered quality-of-life tests as putative patient reported outcomes (PROs): Short Form Health Survey (SF-36) and Sarcopenia Quality of Life (SarQol) for all subjects; in addition, TSD-OC for participants with BMI≥30
Exploratory objectives are :
- To measure tentative biomarkers of sarcopenia and poor physical performance, and test their correlation with physical function change over the study observation.
- To record actimetry via a connected wearable device, in order to describe daily physical activity and possibly identify patterns predictive of improvement/worsening of physical function.
Primary endpoints are the 6-minute Walk Test/400m Walking Test and Co-Primary endpoints are SF-36 and SarQoL for all subjects; additionally TSD-OC for subjects with BMI ≥ 30.
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Being tested
- No Drug and no aspecific intervention
- Keywords
- Sarcopenia, Sarcopenic Obesity, observational study, 6-minute walking distance, 400 meters walking test, Patient Reported Outcomes
- Medical subject headings
- Sarcopenia, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Drug and no aspecific interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute or 400 meters walk.
The 6 minutes walking distance is a functional exercise capacity test that involves measuring the distance covered by a participant within a specified time of 6 minutes. The 400 meter walking test is a measure of how long it will take for a volunteer to complete the specified 400 meters distance.
Measured: Change from Baseline 6 minute or 400 meters to measurement at 6 months.
Secondary outcomes (11)
SPPB
Physical performance tests corresponding to standing balance, walking speed and chair stand will be assessed
Measured: Change from Baseline SPPB to measurement at 6 months.
DEXA
Body composition especially Lean Body Mass and Fat Mass will be measured. This will allow definition of the appendicular Lean Body mass.
Measured: Change from Baseline DEXA to measurement at 6 months.
Stair Climb Power Test
The ability to ascend and descend stairs (9 stairs of 20 cm height) will be assessed in a specific period of time
Measured: Change from Baseline Stair Climb Power Test to measurement at 6 months.
Actimetry
The continuous physical activity of the volunteers will be recorded using a specific device during the 6-month study period.
Measured: Change from actimetry at Month1 to measurement at 6 months.
Grip strength
The grip strength will be measured using the appropriate dynamometer. Strength will be measured 3 times for both hands and the highest value will be kept for further analysis.
Measured: Change from Baseline Grip Strength to measurement at 6 months.
Knee extension
The knee extension measurement will be performed using isokinetic dynamometer.
Measured: Change from Baseline knee extension to measurement at 6 months.
Patient Reported Outcome : SF-36
Electronically self administrated Patient Reported Outcome SF-36 will be assessed a SF-36 questionnaire.
Measured: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes : SarQoL
Electronically self administrated Patient Reported Outcome SarQoL will be assessed through the SarQoL questionnaire.
Measured: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes TSC-OD for patients with BMI>30
Electronically self administrated Patient Reported Outcomes will be assessed through the TSD-OC questionnaire for volunteers having BMI>30
Measured: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes (PAT-D)
Electronically administrated Patient Reported Outcome will be assessed with assistance of the investigator through the PAT-D questionnaire.
Measured: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Biomarkers
Biomarkers specific to Sarcopenia and to the Renin Angiotensin System ( Aldosterone; Renin; Myostatin; PIIINP; IL-6; hsCRP etc....) will be measured at baseline and at 6 months.
Measured: Change from Baseline Biomarkers to measurement at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion30 Nov 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biophytis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Agus, MD, Study director, Biophytis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021798
- Sponsor's protocol ID
- BIO101-CL02
- Acronym
- SARA-OBS
- Status last verified
- Jul 2020
- First submitted
- 3 Jan 2017
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Fielding RA, Rolland Y, Bruyere O, Desvarieux M, Donini LM, Incalzi RA, Muscaritoli M, Tchalla A, Bonnefoy M, Rondanelli M, Van Maanen R, Mariani J, Margalef C, Del Signore S, Tourette C, Dioh W, Veillet S. Characterizing sarcopenia and sarcopenic obesity in patients aged 65 years and over, at risk of mobility disability: a multicenter observational trial (SARA-OBS). BMC Geriatr. 2025 Aug 4;25(1):590. doi: 10.1186/s12877-025-05895-9.
PubMed 40759914
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)
- ClinicalTrials.gov ID
- NCT03021798
- Acronym / sponsor ID
- SARA-OBS / BIO101-CL02
- Conditions
- Sarcopenia, Gait Disorders in Old Age, Muscle Weakness
- Keywords
- Sarcopenia, Sarcopenic Obesity, observational study, 6-minute walking distance, 400 meters walking test, Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- BiophytisIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 16 Jan 2017 (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 SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no therapeutic intervention that will be conducted in three European countries, (Belgium, France and Italy), and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
Participants aged ≥ 65 years complaining of poor physical function will be selected to perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI < 0.789 in men and 0.512 in women will be included. The investigational phase will comprise two main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test and the 400-metre walking test will be administered at the main visits. Patient Reported Outcomes (PROs) will be completed by the patients at the same visits.
Detailed description
The SARA-OBS is a phase 2 clinical trial, with no investigational product and no therapeutic intervention. It will be conducted in three European countries, Belgium, France and Italy, and in the US.
300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability, will undergo mobility functional evaluation and Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at six-month interval.
The general objective is to characterise sarcopenia including "sarcopenic obesity" in a population of older persons living in the community and at risk of mobility disability; evaluate their physical performance and body composition in view of the design of a phase 2 clinical study on the efficacy and safety of BIO101 on the prevention of mobility disability in the at-risk community dwelling older adults (≥65 years) reporting loss of physical function.
The primary objective characterise sarcopenia including sarcopenic obesity, in older persons at risk of mobility disability. Sarcopenia will be defined according to the criteria of the Foundation of NIH; the risk of mobility disability will be operationalised by the Short Physical Performance Battery (SPPB). For this purpose, the 6-minute walking distance and the 400-meter walking test will be evaluated at 6-month intervals, in the absence of any therapeutic intervention. The incident rate of change will be estimated on the sample and pre-specified subgroups (e.g. gender, SPPB baseline score, etc.).
Two important Secondary Objectives are also included :
- To evaluate muscle strength (handgrip/knee extension) and stair power climbing test
- To evaluate self-administered quality-of-life tests as putative patient reported outcomes (PROs): Short Form Health Survey (SF-36) and Sarcopenia Quality of Life (SarQol) for all subjects; in addition, TSD-OC for participants with BMI≥30
Exploratory objectives are :
- To measure tentative biomarkers of sarcopenia and poor physical performance, and test their correlation with physical function change over the study observation.
- To record actimetry via a connected wearable device, in order to describe daily physical activity and possibly identify patterns predictive of improvement/worsening of physical function.
Primary endpoints are the 6-minute Walk Test/400m Walking Test and Co-Primary endpoints are SF-36 and SarQoL for all subjects; additionally TSD-OC for subjects with BMI ≥ 30.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 300 community dwelling older adults (men or women≥65 years) reporting loss of physical function and at risk of mobility disability
Key inclusion criteria (3 listed)
- Men and women aged ≥ 65 years and living in the community, reporting loss of physical function
- Short Physical Performance Battery (SPPB) score ≤ 8
- ALM/BMI < 0.789 in men and 0.512 in women, by DXA scan
Key exclusion criteria (18 listed)
- Unable or unwilling to provide informed consent
- Unable to understand and perform the functional tests, as judged by the Investigator
- Current treatment with anabolic drugs, i.e. testosterone
- Clinical conditions:
- Current physical/rehabilitation therapy
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 |
|---|---|---|
| No Drug and no aspecific interventionNo intervention | Other | – |
Primary outcome
6-minute or 400 meters walk.
Time frame: Change from Baseline 6 minute or 400 meters to measurement at 6 months.
The 6 minutes walking distance is a functional exercise capacity test that involves measuring the distance covered by a participant within a specified time of 6 minutes. The 400 meter walking test is a measure of how long it will take for a volunteer to complete the specified 400 meters distance.
11 secondary outcomes
SPPB
Time frame: Change from Baseline SPPB to measurement at 6 months.
DEXA
Time frame: Change from Baseline DEXA to measurement at 6 months.
Stair Climb Power Test
Time frame: Change from Baseline Stair Climb Power Test to measurement at 6 months.
Actimetry
Time frame: Change from actimetry at Month1 to measurement at 6 months.
Grip strength
Time frame: Change from Baseline Grip Strength to measurement at 6 months.
Knee extension
Time frame: Change from Baseline knee extension to measurement at 6 months.
Patient Reported Outcome : SF-36
Time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes : SarQoL
Time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes TSC-OD for patients with BMI>30
Time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Patient Reported Outcomes (PAT-D)
Time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
Biomarkers
Time frame: Change from Baseline Biomarkers to measurement at 6 months
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 13 Jul 2020.
- Derived from this study: PubMed 40759914Fielding RA, Rolland Y, Bruyere O, Desvarieux M, Donini LM, Incalzi RA, Muscaritoli M, Tchalla A, Bonnefoy M, Rondanelli M, Van Maanen R, Mariani J, Margalef C, Del Signore S, Tourette C, Dioh W, Veillet S. Characterizing sarcopenia and sarcopenic obesity in patients aged 65 years and over, at risk of mobility disability: a multicenter observational trial (SARA-OBS). BMC Geriatr. 2025 Aug 4;25(1):590. doi: 10.1186/s12877-025-05895-9.
- Individual participant dataSharing planned: Undecided
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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.
Samuel Agus, MD study director
Biophytis
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Gait Disorders in Old Age, run by Biophytis at 7 sites in 4 countries.
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 3 inclusion and 18 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 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, France, Belgium, Italy. 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?
6-minute or 400 meters walk. (time frame: Change from Baseline 6 minute or 400 meters to measurement at 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021798, which also lists 1 linked publication.
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 13 Jul 2020.