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NCT Number: NCT05343286

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

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.

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Key information

Conditions

Elderly

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Procedure

blood sample before and after 12 weeks of physical activity

physical assessement

Other

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 assessment

Behavioral

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

Primary outcomes

  1. muscle power

    Time frame: before and after 12 week of physical activity program

    muscle power (Watt/Kg) assessed with the isokinetic ergometer.

Secondary outcomes

  1. Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity)

    Time frame: at day 0

    Change in the amino acid composition (metabolomic signature) at Day 0 between the groups

  2. Change in the amino acid composition (metabolomic signature) after 3 month of physical activity

    Time frame: between Day 0 and Month 3

    Change 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

  3. ICOPE Monitor Assessment

    Time frame: before and after 12 week of physical activity program

    Score of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome)

  4. Sit-to-stand Test

    Time frame: before and after 12 week of physical activity program

    number of movement

  5. Quantified Gait Analysis (QAM)

    Time frame: before and after 12 week of physical activity program

    Gait velocity in m.s-1

  6. Bone densitometer measurement of body composition

    Time frame: before and after 12 week of physical activity program

    % of lean mass

  7. Cognitive tests

    Time frame: before and after 12 week of physical activity program

    Score Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome)

  8. The long questionnaire of personality traits

    Time frame: before and after 12 week of physical activity program

    Score of Big Five Inventory, 0-44, higher score means worse outcome

  9. Perceived health (Score of the scale)

    Time frame: before and after 12 week of physical activity program

    Score of the scale, 0-6, higher score means better outcome

  10. Subjective age

    Time frame: before and after 12 week of physical activity program

    Subjective age in years

  11. Age group identification (Years)

    Time frame: before and after 12 week of physical activity program

    Age group identification in years

  12. Attitudes towards aging

    Time frame: before and after 12 week of physical activity program

    Score on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome

  13. Physical self-perception

    Time frame: before and after 12 week of physical activity program

    Score on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome

  14. Motivation scale for physical activity for health purposes

    Time frame: before and after 12 week of physical activity program

    Score on the Motivation Scale for Physical Activity in a Health Context,0-30, higher score means better outcome

  15. Aging Stereotypes and Exercise Scale

    Time frame: before and after 12 week of physical activity program

    Score on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome

  16. Improvement of muscle force

    Time frame: before and after 12 week of physical activity program

    Improvement of muscle force (N/Kg) assessed with the isokinetic ergometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Fréderic CHORIN, PhD

CONTACT

[email protected]

0492034924

Olivier GUERIN, PU-PH

CONTACT

[email protected]

0492034194

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: BioFaSt

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2022
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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