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
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.