An OBServational Clinical Trial (SARA-OBS) in Sarcopenia and Sarcopenic Obesity in Patients Aged 65 Years and Over

Completed

Conditions studied: Sarcopenia, Gait Disorders in Old Age, Muscle Weakness

In brief

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.

Key facts

Study ID

NCT03021798

Run by

Biophytis

People needed

218

Starts

2017-02-08

Expected to finish

2020-06-30

Last updated by the study team

2020-07-13

Who can join

Age: 65 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.

Where it is running

• Institut On Aging — Gainesville, Florida, United States
• Jean Mayer USDA Human Nutrition research Center on Aging Tufts University — Boston, Massachusetts, United States
• Columbia University New York — New York, New York, United States
• Université de Liège — Liège, Belgium
• Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet — Pierre-Bénite, France
• Gérontopole Toulouse — Toulouse, France
• Sapienza University of Rome — Roma, Italy

Full record on ClinicalTrials.gov

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