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Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity

Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05343286
Acronym
BioFaSt
Enrollment
900
Registered
2022-04-25
Start date
2022-04-29
Completion date
2028-04-15
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly

Brief summary

Physical activity is one of the most effective therapeutic interventions for frailty, sarcopenia or dynapenia. The benefits of physical activity processes are already widely documented. Typically, researchers want to understand the average response to an intervention to determine its overall effectiveness. However, sports trainers have understood it for a long time, the response of an athlete or a patient to training is very variable and the standard deviations present in all the scientific studies on the subject confirm it. There is therefore inter-individual variation in the response to exercise, with some subjects showing much greater improvements than others. Thus, one can wonder if this non-response following training is specific to the training modality. The effects of physical exercise on the body depend mainly on its type, intensity and duration. Thus, from a practical point of view, the most important perspective is the prediction and, ultimately, the individual optimization of management through physical activity.

Detailed description

Main objective: To determine the effects of personalized physical activity management on the biological signatures of muscle failure. Secondary objectives: * Propose a support system through adapted and individualized physical activity, based on physical, biological and psycho-social indicators * Identify the biological signatures (metabolomics, epigenetic) of muscle failure in the elderly. Phenotype responders and non-responders in training 900 seniors (300 per group) APAP group: adapted and personalized physical activity APA group: adapted physical activity Control group: no physical activity Total duration of the study 5 years, duration of participation for a patient 3 months; inclusion period: 57 months Improvement of muscle failure in its broad definition (Strength, power, speed and lean mass) ) General data: description of characteristics with frequencies and percentage for categorical variables and with mean and standard deviation for quantitative variables. ii) Analysis of the primary endpoint: Machine Learning (or supervised classification) and signaling pathway prediction approaches for statistical analysis and data interpretation. iii) Analysis of secondary judgment criteria: approaches in Machine Learning (or supervised classification) and signaling pathway prediction for statistical analysis and interpretation of data with comparison of quantitative variables by Pearson correlation and categorical variables by t or chi 2 test depending on the case. Adapt and individualize physical activity support for healthy or frail elderly people

Interventions

PROCEDUREblood sample

blood sample before and after 12 weeks of physical activity

OTHERphysical assessement

physical assessement before and after 12 weeks of physical activity * Standardized geriatric assessment (physician visit) * ICOPE Monitor Assessment * Sit-to-stand Test * Quantified Gait Analysis (QAM) * Bone densitometer measurement of body composition

Psychometric questionnaires * Cognitive tests (MMSE) * The long questionnaire of personality traits: Big Five Inventory * Perceived health and subjective age * Age group identification * Attitudes towards aging: French version of the Attitudes Toward Own Aging scale * Physical self-perception: French version of the Physical Self-Perception Profile * MOTIVATION SCALE FOR PA FOR HEALTH PURPOSES: Motivation Scale for Physical Activity in a Health Context * Aging Stereotypes and Exercise Scale

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age greater than or equal to 60 years * Affiliated patient or beneficiary of a social security scheme * Patient having signed a prior informed consent.

Exclusion criteria

* Neurocognitive disorder preventing the expression of informed consent * Patients protected by law under guardianship or curatorship, or who cannot participate in a clinical study under Article L. 1121-16 of the French Public Health Code * Presence of a physical or cognitive pathology preventing the performance of the adapted physical activity protocol over 3 months.

Design outcomes

Primary

MeasureTime frameDescription
muscle powerbefore and after 12 week of physical activity programmuscle power (Watt/Kg) assessed with the isokinetic ergometer.

Secondary

MeasureTime frameDescription
Change in the amino acid composition (metabolomic signature) after 3 month of physical activitybetween Day 0 and Month 3Change in the amino acid composition (metabolomic signature) after 3 month of physical activity for the APA and APAP groups compared to the no physical activity group
ICOPE Monitor Assessmentbefore and after 12 week of physical activity programScore of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome)
Sit-to-stand Testbefore and after 12 week of physical activity programnumber of movement
Quantified Gait Analysis (QAM)before and after 12 week of physical activity programGait velocity in m.s-1
Bone densitometer measurement of body compositionbefore and after 12 week of physical activity program% of lean mass
Cognitive testsbefore and after 12 week of physical activity programScore Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome)
The long questionnaire of personality traitsbefore and after 12 week of physical activity programScore of Big Five Inventory, 0-44, higher score means worse outcome
Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity)at day 0Change in the amino acid composition (metabolomic signature) at Day 0 between the groups
Subjective agebefore and after 12 week of physical activity programSubjective age in years
Age group identification (Years)before and after 12 week of physical activity programAge group identification in years
Attitudes towards agingbefore and after 12 week of physical activity programScore on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome
Physical self-perceptionbefore and after 12 week of physical activity programScore on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome
Motivation scale for physical activity for health purposesbefore and after 12 week of physical activity programScore on the Motivation Scale for Physical Activity in a Health Context,0-30, higher score means better outcome
Aging Stereotypes and Exercise Scalebefore and after 12 week of physical activity programScore on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome
Improvement of muscle forcebefore and after 12 week of physical activity programImprovement of muscle force (N/Kg) assessed with the isokinetic ergometer.
Perceived health (Score of the scale)before and after 12 week of physical activity programScore of the scale, 0-6, higher score means better outcome

Countries

France

Contacts

Primary ContactOlivier GUERIN, PU-PH
guerin.o@chu-nice.fr0492034194
Backup ContactFréderic CHORIN, PhD
chorin.f@chu-nice.fr0492034924

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026