<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03021798</url>
  </required_header>
  <id_info>
    <org_study_id>BIO101-CL02</org_study_id>
    <nct_id>NCT03021798</nct_id>
  </id_info>
  <brief_title>An OBServational Clinical Trial (SARA-OBS) in Sarcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over</brief_title>
  <acronym>SARA-OBS</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biophytis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biophytis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The SARA-OBS is a single arm phase 2 clinical trial, with no investigational product and no&#xD;
      therapeutic intervention that will be conducted in three European countries, (Belgium, France&#xD;
      and Italy), and in the US.&#xD;
&#xD;
      300 community dwelling older adults (men or women≥65 years) reporting loss of physical&#xD;
      function and at risk of mobility disability, will undergo mobility functional evaluation and&#xD;
      Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at&#xD;
      six-month interval.&#xD;
&#xD;
      Participants aged ≥ 65 years complaining of poor physical function will be selected to&#xD;
      perform SPPB (Short Physical Performance Battery)tests. Those with SPPB scores ≤ 8/12 will be&#xD;
      selected to perform body composition analysis with DXA Scan. Participants with ALM/BMI &lt;&#xD;
      0.789 in men and 0.512 in women will be included. The investigational phase will comprise two&#xD;
      main visits: the inclusion visit and the 6-month visit. Both the 6-minute walk distance test&#xD;
      and the 400-metre walking test will be administered at the main visits. Patient Reported&#xD;
      Outcomes (PROs) will be completed by the patients at the same visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SARA-OBS is a phase 2 clinical trial, with no investigational product and no therapeutic&#xD;
      intervention. It will be conducted in three European countries, Belgium, France and Italy,&#xD;
      and in the US.&#xD;
&#xD;
      300 community dwelling older adults (men or women≥65 years) reporting loss of physical&#xD;
      function and at risk of mobility disability, will undergo mobility functional evaluation and&#xD;
      Dual-energy X-ray Absorptiometry DXA scan for body composition determination twice, at&#xD;
      six-month interval.&#xD;
&#xD;
      The general objective is to characterise sarcopenia including &quot;sarcopenic obesity&quot; in a&#xD;
      population of older persons living in the community and at risk of mobility disability;&#xD;
      evaluate their physical performance and body composition in view of the design of a phase 2&#xD;
      clinical study on the efficacy and safety of BIO101 on the prevention of mobility disability&#xD;
      in the at-risk community dwelling older adults (≥65 years) reporting loss of physical&#xD;
      function.&#xD;
&#xD;
      The primary objective characterise sarcopenia including sarcopenic obesity, in older persons&#xD;
      at risk of mobility disability. Sarcopenia will be defined according to the criteria of the&#xD;
      Foundation of NIH; the risk of mobility disability will be operationalised by the Short&#xD;
      Physical Performance Battery (SPPB). For this purpose, the 6-minute walking distance and the&#xD;
      400-meter walking test will be evaluated at 6-month intervals, in the absence of any&#xD;
      therapeutic intervention. The incident rate of change will be estimated on the sample and&#xD;
      pre-specified subgroups (e.g. gender, SPPB baseline score, etc.).&#xD;
&#xD;
      Two important Secondary Objectives are also included :&#xD;
&#xD;
        1. To evaluate muscle strength (handgrip/knee extension) and stair power climbing test&#xD;
&#xD;
        2. To evaluate self-administered quality-of-life tests as putative patient reported&#xD;
           outcomes (PROs): Short Form Health Survey (SF-36) and Sarcopenia Quality of Life&#xD;
           (SarQol) for all subjects; in addition, TSD-OC for participants with BMI≥30&#xD;
&#xD;
      Exploratory objectives are :&#xD;
&#xD;
        1. To measure tentative biomarkers of sarcopenia and poor physical performance, and test&#xD;
           their correlation with physical function change over the study observation.&#xD;
&#xD;
        2. To record actimetry via a connected wearable device, in order to describe daily physical&#xD;
           activity and possibly identify patterns predictive of improvement/worsening of physical&#xD;
           function.&#xD;
&#xD;
      Primary endpoints are the 6-minute Walk Test/400m Walking Test and Co-Primary endpoints are&#xD;
      SF-36 and SarQoL for all subjects; additionally TSD-OC for subjects with BMI ≥ 30.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>6-minute or 400 meters walk.</measure>
    <time_frame>Change from Baseline 6 minute or 400 meters to measurement at 6 months.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SPPB</measure>
    <time_frame>Change from Baseline SPPB to measurement at 6 months.</time_frame>
    <description>Physical performance tests corresponding to standing balance, walking speed and chair stand will be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DEXA</measure>
    <time_frame>Change from Baseline DEXA to measurement at 6 months.</time_frame>
    <description>Body composition especially Lean Body Mass and Fat Mass will be measured. This will allow definition of the appendicular Lean Body mass.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stair Climb Power Test</measure>
    <time_frame>Change from Baseline Stair Climb Power Test to measurement at 6 months.</time_frame>
    <description>The ability to ascend and descend stairs (9 stairs of 20 cm height) will be assessed in a specific period of time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actimetry</measure>
    <time_frame>Change from actimetry at Month1 to measurement at 6 months.</time_frame>
    <description>The continuous physical activity of the volunteers will be recorded using a specific device during the 6-month study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength</measure>
    <time_frame>Change from Baseline Grip Strength to measurement at 6 months.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee extension</measure>
    <time_frame>Change from Baseline knee extension to measurement at 6 months.</time_frame>
    <description>The knee extension measurement will be performed using isokinetic dynamometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcome : SF-36</measure>
    <time_frame>Change from Baseline Patient Reported Outcome to measurement at 6 months.</time_frame>
    <description>Electronically self administrated Patient Reported Outcome SF-36 will be assessed a SF-36 questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes : SarQoL</measure>
    <time_frame>Change from Baseline Patient Reported Outcome to measurement at 6 months.</time_frame>
    <description>Electronically self administrated Patient Reported Outcome SarQoL will be assessed through the SarQoL questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes TSC-OD for patients with BMI&gt;30</measure>
    <time_frame>Change from Baseline Patient Reported Outcome to measurement at 6 months.</time_frame>
    <description>Electronically self administrated Patient Reported Outcomes will be assessed through the TSD-OC questionnaire for volunteers having BMI&gt;30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes (PAT-D)</measure>
    <time_frame>Change from Baseline Patient Reported Outcome to measurement at 6 months.</time_frame>
    <description>Electronically administrated Patient Reported Outcome will be assessed with assistance of the investigator through the PAT-D questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers</measure>
    <time_frame>Change from Baseline Biomarkers to measurement at 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Sarcopenia</condition>
  <condition>Gait Disorders in Old Age</condition>
  <condition>Muscle Weakness</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Drug and no aspecific intervention</intervention_name>
    <description>No intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        300 community dwelling older adults (men or women≥65 years) reporting loss of physical&#xD;
        function and at risk of mobility disability&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged ≥ 65 years and living in the community, reporting loss of physical&#xD;
             function&#xD;
&#xD;
          2. Short Physical Performance Battery (SPPB) score ≤ 8&#xD;
&#xD;
          3. ALM/BMI &lt; 0.789 in men and 0.512 in women, by DXA scan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable or unwilling to provide informed consent&#xD;
&#xD;
          2. Unable to understand and perform the functional tests, as judged by the Investigator&#xD;
&#xD;
          3. Current treatment with anabolic drugs, i.e. testosterone&#xD;
&#xD;
          4. Clinical conditions:&#xD;
&#xD;
               1. Current diagnosis major psychiatric disorders.&#xD;
&#xD;
               2. Alcohol abuse or dependence&#xD;
&#xD;
               3. Severe arthritis&#xD;
&#xD;
               4. Cancer requiring active treatment&#xD;
&#xD;
               5. Lung disease requiring regular use of supplemental oxygen&#xD;
&#xD;
               6. Inflammatory conditions requiring regular use of oral or parenteral&#xD;
                  corticosteroid agents&#xD;
&#xD;
               7. Severe cardiovascular disease (including New York Heart Association [NYHA] class&#xD;
                  III or IV congestive heart failure, clinically significant valvular disease,&#xD;
                  history of cardiac arrest, presence of an implantable defibrillator, or&#xD;
                  uncontrolled angina)&#xD;
&#xD;
               8. Parkinson's disease or other progressive neurological disorder&#xD;
&#xD;
               9. Renal disease requiring dialysis&#xD;
&#xD;
              10. Chest pain, severe shortness of breath, or occurrence of other safety concerns&#xD;
                  during the baseline the 6MWT, or the 400-meter walk test&#xD;
&#xD;
          5. Current physical/rehabilitation therapy&#xD;
&#xD;
          6. Current enrolment in another clinical trial&#xD;
&#xD;
          7. Concomitant condition implying life expectancy ≤ 6 months&#xD;
&#xD;
          8. Any other condition precluding the regular participation to the clinical trial, as&#xD;
             judged by the Investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Agus, MD</last_name>
    <role>Study Director</role>
    <affiliation>Biophytis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut On Aging</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jean Mayer USDA Human Nutrition research Center on Aging Tufts University</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Université de Liège</name>
      <address>
        <city>Liège</city>
        <zip>4020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gérontopole Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapienza University of Rome</name>
      <address>
        <city>Roma</city>
        <zip>00185</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sarcopenia</keyword>
  <keyword>Sarcopenic Obesity</keyword>
  <keyword>observational study</keyword>
  <keyword>6-minute walking distance</keyword>
  <keyword>400 meters walking test</keyword>
  <keyword>Patient Reported Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Weakness</mesh_term>
    <mesh_term>Sarcopenia</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03021798
org study id: BIO101-CL02
nct id: NCT03021798
lead sponsor: 
has dmc: No
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.
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 :

        1. To evaluate muscle strength (handgrip/knee extension) and stair power climbing test

        2. 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 :

        1. To measure tentative biomarkers of sarcopenia and poor physical performance, and test
           their correlation with physical function change over the study observation.

        2. 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.
observational model: Cohort
time perspective: Prospective
measure: 6-minute or 400 meters walk.
time frame: Change from Baseline 6 minute or 400 meters to measurement at 6 months.
description: 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.
measure: SPPB
time frame: Change from Baseline SPPB to measurement at 6 months.
description: Physical performance tests corresponding to standing balance, walking speed and chair stand will be assessed
measure: DEXA
time frame: Change from Baseline DEXA to measurement at 6 months.
description: Body composition especially Lean Body Mass and Fat Mass will be measured. This will allow definition of the appendicular Lean Body mass.
measure: Stair Climb Power Test
time frame: Change from Baseline Stair Climb Power Test to measurement at 6 months.
description: The ability to ascend and descend stairs (9 stairs of 20 cm height) will be assessed in a specific period of time
measure: Actimetry
time frame: Change from actimetry at Month1 to measurement at 6 months.
description: The continuous physical activity of the volunteers will be recorded using a specific device during the 6-month study period.
measure: Grip strength
time frame: Change from Baseline Grip Strength to measurement at 6 months.
description: 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.
measure: Knee extension
time frame: Change from Baseline knee extension to measurement at 6 months.
description: The knee extension measurement will be performed using isokinetic dynamometer.
measure: Patient Reported Outcome : SF-36
time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
description: Electronically self administrated Patient Reported Outcome SF-36 will be assessed a SF-36 questionnaire.
measure: Patient Reported Outcomes : SarQoL
time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
description: Electronically self administrated Patient Reported Outcome SarQoL will be assessed through the SarQoL questionnaire.
measure: Patient Reported Outcomes TSC-OD for patients with BMI>30
time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
description: Electronically self administrated Patient Reported Outcomes will be assessed through the TSD-OC questionnaire for volunteers having BMI>30
measure: Patient Reported Outcomes (PAT-D)
time frame: Change from Baseline Patient Reported Outcome to measurement at 6 months.
description: Electronically administrated Patient Reported Outcome will be assessed with assistance of the investigator through the PAT-D questionnaire.
measure: Biomarkers
time frame: Change from Baseline Biomarkers to measurement at 6 months
description: 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.
intervention type: Other
intervention name: No Drug and no aspecific intervention
description: No intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 95 Years
healthy volunteers: No
last name: Samuel Agus, MD
role: Study Director
affiliation: Biophytis
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
country: Italy
country: United States
responsible party type: Sponsor
mesh term: Muscle Weakness
mesh term: Sarcopenia
mesh term: Obesity
sharing ipd: Undecided