Clinical trial NCT04080063: Biological Markers of Functional Effects of Physical Activity in an Elderly Population
Official title: Biological Markers of Functional Effects of Physical Activity : Aging, Immunometabolism and Frailty Project (VIF-APAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fragility
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: analysis of phenotype of circulating T cells
timeFrame: change from baseline physical activity at 3 months
measure: Concentration of mRNAs related to PPARβ/δ gene expression
timeFrame: change from baseline physical activity at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: guerin.o@chu-nice.fr
name: Olivier GUERIN
role: PRINCIPAL_INVESTIGATOR
References: