An OBServational Clinical Trial (SARA-OBS) in Sarcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over
Condition: Sarcopenia; Gait Disorders in Old Age; Muscle Weakness
MeSH terms: Muscle Weakness; Sarcopenia; Obesity
Study type: Observational

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.

      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 :

        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.
    

Intervention name(s): No Drug and no aspecific intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        300 community dwelling older adults (men or women≥65 years) reporting loss of physical
        function and at risk of mobility disability
      
Keywords: Sarcopenia; Sarcopenic Obesity; observational study; 6-minute walking distance; 400 meters walking test; Patient Reported Outcomes