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

Elderly Clinical Trial

— BioFaSt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05343286
• Other study ID #: 21-PP-24
• Status: Recruiting
• Phase: N/A
• Start date: April 29, 2022
• Est. completion date: April 15, 2027

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Olivier GUERIN, PU-PH
• Phone: 0492034194
• Email: guerin.o[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: April 15, 2027
• Est. primary completion date: April 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly

Intervention

Procedure:
• blood sample
blood sample before and after 12 weeks of physical activity

Other:
• physical 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

Behavioral:
• psychometric assessment
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

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle power	muscle power (Watt/Kg) assessed with the isokinetic ergometer.	before and after 12 week of physical activity program
Secondary	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	at day 0
Secondary	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	between Day 0 and Month 3
Secondary	ICOPE Monitor Assessment	Score of frailty. (Implementation of the Integrated Care of Older People, ICOPmonitor, 8 item, higher score means worse outcome)	before and after 12 week of physical activity program
Secondary	Sit-to-stand Test	number of movement	before and after 12 week of physical activity program
Secondary	Quantified Gait Analysis (QAM)	Gait velocity in m.s-1	before and after 12 week of physical activity program
Secondary	Bone densitometer measurement of body composition	% of lean mass	before and after 12 week of physical activity program
Secondary	Cognitive tests	Score Mini-Mental State Examination (MMSE, 0-30, higher score mean worse outcome)	before and after 12 week of physical activity program
Secondary	The long questionnaire of personality traits	Score of Big Five Inventory, 0-44, higher score means worse outcome	before and after 12 week of physical activity program
Secondary	Perceived health (Score of the scale)	Score of the scale, 0-6, higher score means better outcome	before and after 12 week of physical activity program
Secondary	Subjective age	Subjective age in years	before and after 12 week of physical activity program
Secondary	Age group identification (Years)	Age group identification in years	before and after 12 week of physical activity program
Secondary	Attitudes towards aging	Score on the French version of the Attitudes Toward Own Aging scales, 0-7, higher score means better outcome	before and after 12 week of physical activity program
Secondary	Physical self-perception	Score on the French version of the Physical Self-Perception Profile, 0-6, higher score means better outcome	before and after 12 week of physical activity program
Secondary	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	before and after 12 week of physical activity program
Secondary	Aging Stereotypes and Exercise Scale	Score on the French Aging Stereotypes and Exercise Scale (ASES), 0-12, higher score means better outcome	before and after 12 week of physical activity program
Secondary	Improvement of muscle force	Improvement of muscle force (N/Kg) assessed with the isokinetic ergometer.	before and after 12 week of physical activity program