ElderlyBioFaStNCT05343286
Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity
A study testing blood sample, physical assessement and psychometric assessment in people with Elderly, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- blood sample, physical assessement and psychometric assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2022to 15 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 60 years
- Affiliated patient or beneficiary of a social security scheme
- Patient having signed a prior informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06000
Olivier Guérin, PU-PH, +33 (0)4 92 03 41 94, guerin.o@chu-nice.fr
About this study
Official title: Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA
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.
Read the 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
- Conditions
- Elderly
- Being tested
- blood sample, physical assessement, psychometric assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
blood sample before and after 12 weeks of physical activity
physical assessementOther
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 assessmentBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| APAP group: adapted and personalized physical activity | Experimental | 12 weeks of adapted and personalized physical activity Receives: Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment |
| APA group: adapted physical activity | Active comparator | 12 weeks of generic physical activity Receives: Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment |
| Control group: no physical activity | Sham comparator | no physical activity Receives: Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle power
muscle power (Watt/Kg) assessed with the isokinetic ergometer.
Measured: before and after 12 week of physical activity program
Secondary outcomes (16)
Different metabolomic signature (The amino acid composition) between the groups (APA, APAP, no physical activity)
Change in the amino acid composition (metabolomic signature) at Day 0 between the groups
Measured: at day 0
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 APA and APAP groups compared to the no physical activity group
Measured: between Day 0 and Month 3
ICOPE Monitor Assessment
Score of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome)
Measured: before and after 12 week of physical activity program
Sit-to-stand Test
number of movement
Measured: before and after 12 week of physical activity program
Quantified Gait Analysis (QAM)
Gait velocity in m.s-1
Measured: before and after 12 week of physical activity program
Bone densitometer measurement of body composition
% of lean mass
Measured: before and after 12 week of physical activity program
Cognitive tests
Score Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome)
Measured: before and after 12 week of physical activity program
The long questionnaire of personality traits
Score of Big Five Inventory, 0-44, higher score means worse outcome
Measured: before and after 12 week of physical activity program
Perceived health (Score of the scale)
Score of the scale, 0-6, higher score means better outcome
Measured: before and after 12 week of physical activity program
Subjective age
Subjective age in years
Measured: before and after 12 week of physical activity program
Age group identification (Years)
Age group identification in years
Measured: before and after 12 week of physical activity program
Attitudes towards aging
Score on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome
Measured: before and after 12 week of physical activity program
Physical self-perception
Score on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome
Measured: before and after 12 week of physical activity program
Motivation scale for physical activity for health purposes
Score on the Motivation Scale for Physical Activity in a Health Context,0-30, higher score means better outcome
Measured: before and after 12 week of physical activity program
Aging Stereotypes and Exercise Scale
Score on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome
Measured: before and after 12 week of physical activity program
Improvement of muscle force
Improvement of muscle force (N/Kg) assessed with the isokinetic ergometer.
Measured: before and after 12 week of physical activity program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start29 Apr 2022
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GUERIN, PU-PH, Principal investigator, geriatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343286
- Sponsor's protocol ID
- 21-PP-24
- Acronym
- BioFaSt
- Status last verified
- Nov 2025
- First submitted
- 2 Mar 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological & Fonctional Signatures for Muscle Failures, Aged People & Personalized Physical Activity : BioFaSt MAPPA
- ClinicalTrials.gov ID
- NCT05343286
- Acronym / sponsor ID
- BioFaSt / 21-PP-24
- Conditions
- Elderly
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| APAP group: adapted and personalized physical activity | Experimental | Procedure: blood sample, Other: physical assessement, Behavioral: psychometric assessment12 weeks of adapted and personalized physical activity |
| APA group: adapted physical activity | Active comparator | Procedure: blood sample, Other: physical assessement, Behavioral: psychometric assessment12 weeks of generic physical activity |
| Control group: no physical activity | Sham comparator | Procedure: blood sample, Other: physical assessement, Behavioral: psychometric assessmentno physical activity |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 60 years
- Affiliated patient or beneficiary of a social security scheme
- Patient having signed a prior informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleblood sample before and after 12 weeks of physical activity | Procedure or surgery | APA group: adapted physical activity, APAP group: adapted and personalized physical activity, Control group: no physical activity |
| physical assessementphysical 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 | Other | APA group: adapted physical activity, APAP group: adapted and personalized physical activity, Control group: no physical activity |
| psychometric assessmentPsychometric 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 | Behavioural | APA group: adapted physical activity, APAP group: adapted and personalized physical activity, Control group: no physical activity |
Primary outcome
muscle power
Time frame: before and after 12 week of physical activity program
muscle power (Watt/Kg) assessed with the isokinetic ergometer.
16 secondary outcomes
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) after 3 month of physical activity
Time frame: between Day 0 and Month 3
ICOPE Monitor Assessment
Time frame: before and after 12 week of physical activity program
Sit-to-stand Test
Time frame: before and after 12 week of physical activity program
Quantified Gait Analysis (QAM)
Time frame: before and after 12 week of physical activity program
Bone densitometer measurement of body composition
Time frame: before and after 12 week of physical activity program
Cognitive tests
Time frame: before and after 12 week of physical activity program
The long questionnaire of personality traits
Time frame: before and after 12 week of physical activity program
Perceived health (Score of the scale)
Time frame: before and after 12 week of physical activity program
Subjective age
Time frame: before and after 12 week of physical activity program
Age group identification (Years)
Time frame: before and after 12 week of physical activity program
Attitudes towards aging
Time frame: before and after 12 week of physical activity program
Physical self-perception
Time frame: before and after 12 week of physical activity program
Motivation scale for physical activity for health purposes
Time frame: before and after 12 week of physical activity program
Aging Stereotypes and Exercise Scale
Time frame: before and after 12 week of physical activity program
Improvement of muscle force
Time frame: before and after 12 week of physical activity program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier GUERIN, PU-PH principal investigator
geriatric Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, physical assessement and psychometric assessment in people with Elderly, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier GUERIN, PU-PH (0492034194, guerin.o@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle power (time frame: before and after 12 week of physical activity program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.