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

NCT03021798 | Completed

• 1 other identifier: BIO101-CL02
• Study Type: observational
• Target: 218
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Sarcopenia; Gait Disorders in Old Age; Muscle Weakness

Keywords

Sarcopenia; Sarcopenic Obesity; observational study; 6-minute walking distance; 400 meters walking test; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

• 6-minute or 400 meters walk.

  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.

  Change from Baseline 6 minute or 400 meters to measurement at 6 months.

Secondary Outcomes (11)

• SPPB

  Change from Baseline SPPB to measurement at 6 months.

• DEXA

  Change from Baseline DEXA to measurement at 6 months.

• Stair Climb Power Test

  Change from Baseline Stair Climb Power Test to measurement at 6 months.

• Actimetry

  Change from actimetry at Month1 to measurement at 6 months.

• Grip strength

  Change from Baseline Grip Strength to measurement at 6 months.

Interventions

No Drug and no aspecific intervention OTHER

No intervention

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Biophytis: lead

Study Sites (7)

Institut On Aging

Gainesville, Florida, 32611, United States

Location

Jean Mayer USDA Human Nutrition research Center on Aging Tufts University

Boston, Massachusetts, 02111, United States

Location

Columbia University New York

New York, New York, 10027, United States

Location

Université de Liège

Liège, 4020, Belgium

Location

Centre Hospitalier Lyon Sud 165 Chemin du Grand Revoyet

Pierre-Bénite, 69495, France

Location

Gérontopole Toulouse

Toulouse, France

Location

Sapienza University of Rome

Roma, 00185, Italy

Location

Related Publications (1)

• Fielding RA, Rolland Y, Bruyere O, Desvarieux M, Donini LM, Incalzi RA, Muscaritoli M, Tchalla A, Bonnefoy M, Rondanelli M, Van Maanen R, Mariani J, Margalef C, Del Signore S, Tourette C, Dioh W, Veillet S. Characterizing sarcopenia and sarcopenic obesity in patients aged 65 years and over, at risk of mobility disability: a multicenter observational trial (SARA-OBS). BMC Geriatr. 2025 Aug 4;25(1):590. doi: 10.1186/s12877-025-05895-9.

  PMID: 40759914 DERIVED

MeSH Terms

Conditions

Sarcopenia; Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Study Officials

• Samuel Agus, MD

  Biophytis

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 16, 2017
• Study Start: February 8, 2017
• Primary Completion: November 30, 2019
• Study Completion: June 30, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

BE (1); US (3); FR (2); IT (1)