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Completed

NCT Number: NCT04080063

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

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.

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Key information

Conditions

Fragility

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, 06000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapted physical activity

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.

Primary outcomes

  1. analysis of phenotype of circulating T cells

    Time frame: change from baseline physical activity at 3 months

    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)

  2. Concentration of mRNAs related to PPARβ/δ gene expression

    Time frame: change from baseline physical activity at 3 months

    Analysis of mRNAs from blood sample related to PPARβ/δ gene expression by Luminex technology

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: BIO-APAS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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