Biological Markers of Functional Effects of Physical Activity in an Elderly Population (BIO-APAS)

Biological Markers of Functional Effects of Physical Activity : Aging, Immunometabolism and Frailty Project (VIF-APAS)

Circulating biomarkers are promising tools for the early diagnosis of aging-associated pathologies. Inflammation and immunity are associated with the risk of sarcopenia and frailty in elderly patients. The investigators investigate the effect of an adapted physical activity program on the metabolism and function of circulating immune cells and miRNA in frail and non-frail elderly subjects. Induced immune changes are analyzed together with that of motor abilities and of frailty status.

Study Overview

• Status: Completed
• Conditions: Fragility
• Intervention / Treatment: Other: adapted physical activity

Detailed Description

Circulating biomarkers are promising tools for early diagnosis of pathologies associated with aging. Inflammation and immunity are associated with the risk of sarcopenia and frailty in elderly patients. The investigators investigate the effect of an adapted physical activity program on the metabolism and function of circulating immune cells and miRNA in frail and non-frail elderly subjects. The main objective is to establish the link between biological markers of aging (immune cells phenotypes and function, miRNA) and motor capacities alteration/improvement. The secondary objectives are: (1) to characterize the functional and immunometabolic dimensions of frailty from objective indicators; (2) to propose a management system through adapted and individualized physical activity, based on objective indicators; (3) to evaluate the clinical impact of both frailty and its preventative management through physical activity; and (4) to identified new biomarkers of frailty. A total of 100 patients categorized as frail, pre-frail, and non-frail after a standardized geriatric evaluation are included in a comparative and interventional study. Exercise intervention consists in a 12-weeks physical activity program. Blood sample and physical/psychological functional measurements are performed before and after the 12-weeks physical activity program. ANOVA tests and correlational analysis will be performed. The finality of the study is to improve the medical prescription of physical activities in elderly patients.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient who signed the informed consent
• Older men and women ≥ 65 years
• Can walk without technical help

Exclusion Criteria:

• Patient with protective measures (guardianship, curatorship, and deprivation of liberty).
• Patient with a neurological problem
• No affiliation to a social security scheme (beneficiary or assignee)
• Knee and / or hip prosthesis
• Orthopedic complications with repercussions on walking activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adapted physical activity; a personalized care will be offered in terms of adapted physical activity	Other: adapted physical activity; The study begins with an evaluation of physical strenght and cognitive and psychometric assessment.Then, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analysis of phenotype of circulating T cells	Measurement of T cell populations determined by flow cytometry (FACS) Different antibodies will be used to caracterize different sub-population (CD3+ ; CD4+ ; CD8+ ; T-regulator ; T-helper 1 and 17)	change from baseline physical activity at 3 months
Concentration of mRNAs related to PPARβ/δ gene expression	Analysis of mRNAs from blood sample related to PPARβ/δ gene expression by Luminex technology	change from baseline physical activity at 3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Olivier GUERIN, guerin.o@chu-nice.fr

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): February 21, 2022
• Study Completion (Actual): February 21, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 19-PP-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No