Biological Markers of Functional Effects of Physical Activity in an Elderly Population

NCT ID: NCT04080063

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2022-02-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fragility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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adapted physical activity

a personalized care will be offered in terms of adapted physical activity

Group Type EXPERIMENTAL

adapted physical activity

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier GUERIN

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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19-PP-06

Identifier Type: -

Identifier Source: org_study_id

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