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You can access this
clinical trial
if you have
Sarcopenia
and you are
between 65 and 95
years old
-
This is an observational trial.
You are contributing to medical knowledge about your condition.
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The purpose

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.

Provided treatments

  • Other: No Drug and no aspecific intervention
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Locations near you

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Tris trial is registered with FDA with number: NCT03021798. The sponsor of the trial is Biophytis and it is looking for 300 volunteers for the current phase.
Official trial title:
Characterising SARcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over at Risk of Mobility Disability. An OBServational Clinical Trial (SARA-OBS)