Sarcopenia Physical Activity and Metabolomic (SPAM)

Muscle failure (sarcopenia or dynapenia) is a factor of frailty and therefore, ultimately, of loss of autonomy in the elderly. Currently, no biomarker of muscle failure has a high sensitivity, specificity and positive predictive value. Several results, although preliminary, suggest that metabolomics could facilitate the early identification of frail patients, allowing the implementation of primary prevention strategies. Untargeted high-resolution metabolomics analysis would identify discriminative biomarkers and biological mechanisms associated with frailty. Finally, the hypothesis that metabolic signatures can be identified as risk factors for the development of age-related dynapenia should be tested in a longitudinal design.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: Physical activity programm

Detailed Description

Sarcopenia is defined as decreased muscle strength and low muscle quantity or quality. Screening and management of sarcopenia was modified in early 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP) with the creation of the F-A-C-S (Find-Assess-Confirm-Severity) protocol. The search for sarcopenia (Find) is done during the interrogation of the patient expressing symptoms that may be related to the loss of muscle mass, such as falls, asthenia, weight loss, decreased walking speed, or difficulty getting up from a chair. A simple self-report questionnaire (SARC-F) has been created to facilitate screening. Clinical suspicion of sarcopenia requires the performance of a functional assessment (Assess), using for example grip strength.and the chair lift test to look for decreased muscle strength. A pathological result already allows the suspicion of sarcopenia and the introduction of secondary prophylactic measures. Diagnostic confirmation of sarcopenia (Confirm) can be obtained by demonstrating a decrease in muscle mass by one of four validated techniques: magnetic resonance imaging (MRI), computed tomography (CT), dual-energy X-ray absorptiometry (DXA) (Buckinx et al., 2018), or bioimpedancemetry (Rossi et al., 2014). Sarcopenia is considered severe (Severity) if there is a decrease in overall physical performance objectified by physical tests such as the Time Up and Go Test, walking speed, or the Short Physical Performance Battery (SPPB) test.

The development and validation of a single biomarker could be a simple and cost-effective way to diagnose and monitor individuals with sarcopenia. Potential biomarkers could include markers of neuromuscular junction, muscle protein turnover, behaviorally mediated pathways, inflammation-mediated pathways, redox-related factors, and hormones or other anabolic factors (Curcio et al., 2016). However, due to the complex pathophysiology of sarcopenia, it is unlikely that a single biomarker can identify the disease in the heterogeneous population of young and old. Instead, the development of a panel of biomarkers should be considered, including potential serum markers and tissue markers. Implementing a multidimensional methodology for modeling these pathways could provide a means to stratify risk for sarcopenia, facilitate identification of worsening of the condition, and track treatment efficacy.

In the context of physical frailty and sarcopenia, the study of dynamic metabolic responses to stressors and the characterization of the biochemical pathways involved are particularly relevant, as this condition is closely associated with metabolic disorders. Disturbances in protein and amino acid metabolism may contribute substantially to the pathophysiology of sarcopenia.

The hypothesis that metabolic signatures can be identified as risk factors for the development of age-related sarcopenia needs to be tested in a longitudinal design.

The main objective is to Identify metabolomic signatures of muscle failure in the elderly.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age greater than or equal to 65 years;
• Patient affiliated or beneficiary of a social security plan;
• Patient having signed a prior informed consent

Exclusion Criteria:

• presence of a physical or cognitive pathology preventing the performance of the physical activity protocol during 3 months
• Patient with legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarcopenic patient; Patient with sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)	Behavioral: Physical activity programm; adapted physical activity during 3 month
Active Comparator: Non sarcopenic patient; Patient without sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)	Behavioral: Physical activity programm; adapted physical activity during 3 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Different metabolomic signature (The amino acid composition) between the sarcopenic group and the control group	Change in the amino acid composition (metabolomic signature) at Day 0 between the sarcopenic group and the control group	at Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the amino acid composition (metabolomic signature) after 3 month of physical activity	Change in the amino acid composition (metabolomic signature) after 3 month of physical activity for the sarcopenic group compared to the control group	between Day 0 and Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Emeline MICHEL, MD, Nice University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): April 22, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: 20-AOI-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No