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

NCT05343286 | Recruiting

• 1 other identifier: 21-PP-24
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly

Outcome Measures

Primary Outcomes (1)

• muscle power

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

  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)

  at day 0

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

  between Day 0 and Month 3

• ICOPE Monitor Assessment

  before and after 12 week of physical activity program

• Sit-to-stand Test

  before and after 12 week of physical activity program

• Quantified Gait Analysis (QAM)

  before and after 12 week of physical activity program

Study Arms (3)

APAP group: adapted and personalized physical activity

EXPERIMENTAL

12 weeks of adapted and personalized physical activity

Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment

APA group: adapted physical activity

ACTIVE COMPARATOR

12 weeks of generic physical activity

Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment

Control group: no physical activity

SHAM COMPARATOR

no physical activity

Procedure: blood sample; Other: physical assessement; Behavioral: psychometric assessment

Interventions

blood sample PROCEDURE

blood sample before and after 12 weeks of physical activity

APA group: adapted physical activity; APAP group: adapted and personalized physical activity; Control group: no 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

APA group: adapted physical activity; APAP group: adapted and personalized physical activity; Control group: no physical activity

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

APA group: adapted physical activity; APAP group: adapted and personalized physical activity; Control group: no physical activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Olivier GUERIN, PU-PH

  geriatric Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier GUERIN, PU-PH

CONTACT

0492034194; guerin.o@chu-nice.fr

Fréderic CHORIN, PhD

CONTACT

0492034924; chorin.f@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: April 25, 2022
• Study Start: April 29, 2022
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)