Sarcopenia Physical Activity and Metabolomic
SPAM
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2021
CompletedStudy Start
First participant enrolled
January 11, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2022
CompletedJuly 13, 2022
July 1, 2022
3 months
December 16, 2021
July 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in the amino acid composition (metabolomic signature) after 3 month of physical activity
between Day 0 and Month 3
Study Arms (2)
Sarcopenic patient
EXPERIMENTALPatient with sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)
Non sarcopenic patient
ACTIVE COMPARATORPatient without sarcopenic criteria (SARC-F Score, muscle strengh value, appendicular lean mass value)
Interventions
adapted physical activity during 3 month
Eligibility Criteria
You may qualify if:
- Age greater than or equal to 65 years;
- Patient affiliated or beneficiary of a social security plan;
- Patient having signed a prior informed consent
You may not qualify if:
- presence of a physical or cognitive pathology preventing the performance of the physical activity protocol during 3 months
- Patient with legal protection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emeline MICHEL, MD
Nice University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2021
First Posted
January 20, 2022
Study Start
January 11, 2022
Primary Completion
April 22, 2022
Study Completion
July 5, 2022
Last Updated
July 13, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share