Sedentary or Exercised : Neuromuscular and Immunometabolic Observations and Retrospection (SENIOR)

Immunometabolic and Neuromuscular Markers of Vitality Capacity : SENIOR Protocol

The distinction between healthy and pathological ageing has given rise to the vitality capacity concept. Underlying the physiological aspect of ageing, vitality capacity is reflected in the neuromuscular function, metabolism, and immune and stress response. The three domains seem to deteriorate with age, except among individuals who have maintained physical activity throughout their lives. Furthermore, immune cells, particularly T lymphocytes, appear to play a key role in each dimension of vitality capacity, as well as in the mice ageing pathway. Investigators sought to determine the effect of lifelong physical activity on vitality capacity, and especially on T cell metabolism.

In this optic, fourty healthy participants over the age of 55 will be allocated to two groups: 20 who have maintained physical activity for the past 30 years, and 20 who have not. Each participant's vitality capacity will be deeply tested and compared to their physical activity background.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Nice, France, 06000
        • Recruiting
        • CHU de Nice
        • Contact:
        • Principal Investigator:
          • olivier GUERIN, MD
        • Sub-Investigator:
          • anne-sophie ROUSSEAU, PU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  • General Inclusion Criteria:
  • Men and women > 55 years old
  • Participants who are non-smokers or have been weaned for more than 3 years
  • Menopausal women (confirmed for at least 6 months)
  • Participants affiliated to the social security system
  • Signature of informed consent
  • Inclusion Criteria for the active population:
  • Any person with structured aerobic physical activity (mainly involving cardiorespiratory function) on at least 3 days/week over the last 30 years without an interruption of more than 1 week in the 3 months preceding the study and without an interruption of more than 12 consecutive months over the last 30 years, as assessed by an interview conducted by an investigator specialising in physical activity;
  • have a level of physical activity that meets the recommendations for physical activity in terms of the duration and intensity of weekly cardiorespiratory effort (WHO, 2020; ANSES, 2016) according to the criteria assessed by the GPAQ: at least 150 to 300 minutes per week of moderate-intensity aerobic activity (e.g., 5 days of moderate intensity activity of at least 30 minutes/day) or at least 75 to 150 minutes of sustained intensity endurance activity (e.g., 3 days of sustained activity of 25 minutes/day); or an equivalent combination of moderate and sustained intensity activities throughout the week.
  • Inclusion criteria for the inactive population :
  • Any person who does not meet the criteria for inclusion in the 'active' population defined above;
  • Any person who has or has had a low physical intensity professional activity over the last 30 years: sedentary professional activity (work time generally spent in a seated position, such as office work) and/or a standing professional activity (work time spent standing or walking, without intense physical effort (e.g. shop assistant, hairdresser, caretaker, etc.).
  • Anyone who does not practise or has not practised sport, fitness or other physical leisure activities alone or under supervision over the last 30 years, or who practises or has practised, over the last 30 years, a sport, fitness or other physical leisure activity less than or equal to 2 days a week and for a weekly period not exceeding 75 minutes.
  • Anyone whose active mode of transport (cycling, walking) does not exceed an overall duration of 75 minutes per week, and whose consecutive time slots per journey are less than 10 minutes.
  • Non-inclusion Criteria:
  • Person suffering from a chronic illness
  • Anyone who has used performance-enhancing drugs
  • Anyone with a disability
  • Person on medication
  • Recent hospitalisation (within the last 6 months)
  • People with osteoarthritis.
  • Anyone who has had a cardiovascular event in the last 30 years (angina, heart attack)
  • People with a current clinical acute inflammatory condition.
  • People who have practised sport with known vascular complications.
  • Persons under guardianship or trusteeship
  • Exclusion Criteria: withdraw of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physically active

Participants of this group are physically active subjects

- V1 will take place at the Nice University Hospital, in the morning, on an empty stomach.

After signing the consent form, the participant will have a blood sample taken (24mL), answer questionnaire and have a body assessment by bone densitometry. At the end of the appointment , the participant will wear an accelerometer and fill in his or her food intake for one week.

- V2 (approximatly 2 weeks after V1), will take place at LAMHESS, the participant will perform neuromuscular tests on an ergometer, with high-density electromyography (HDEMG) sensors on the thighs.

1 blood withdraw, questionnaire and tests
Experimental: Physically inactive

Participants of this group are physically inactive subjects

- V1 will take place at the Nice University Hospital, in the morning, on an empty stomach.

After signing the consent form, the participant will have a blood sample taken (24mL), answer questionnaire and have a body assessment by bone densitometry. At the end of the appointment , the participant will wear an accelerometer and fill in his or her food intake for one week.

- V2 (approximatly 2 weeks after V1), will take place at LAMHESS, the participant will perform neuromuscular tests on an ergometer, with high-density electromyography (HDEMG) sensors on the thighs.

1 blood withdraw, questionnaire and tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference of T cell metabolism between active and inactive participants
Time Frame: at day 0
On the bloodwithdraw, level of T cells metabolism will be measured by using the SCENITH (Single Cell ENergetIc metabolism by profiling Translation inHibition) method
at day 0
Difference of T cell metabolism between active and inactive participants
Time Frame: at day 0
On the bloodwithdraw, level of T cells metabolism will be measured by RNA sequencing
at day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WHOQOLD-OLD Questionnaire
Time Frame: at day 0
A low score reflects a poor quality of life, whereas a high score does not. 24 questions and 6 dimensions are assessed: physical state, psychological state, mobility, social life, environment and spirituality.
at day 0
Capacity vitality
Time Frame: at day 0 and 14
Evaluating all vitality capacity features regarding Bautmans 2022 guidelines
at day 0 and 14
Neuromuscular parameters
Time Frame: at day 0 and 14
Will be evaluated using HD-EMGs
at day 0 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Olivier GUERIN, MD, Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-PP-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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