NCT04080063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 4, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

August 26, 2019

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

adapted physical activity

EXPERIMENTAL

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

Other: adapted physical activity

Interventions

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.

adapted physical activity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Study Officials

  • Olivier GUERIN

    guerin.o@chu-nice.fr

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

September 6, 2019

Study Start

November 4, 2019

Primary Completion

February 21, 2022

Study Completion

February 21, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations