- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06692543
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne-Sophie Rousseau, PU
- Phone Number: 06,83,52,26,73
- Email: anne-sophie.rousseau@univ-cotedazur.fr
Study Contact Backup
- Name: Frederic CHORIN, PhD
- Phone Number: 04 92 03 49 24
- Email: chorin.f@chu-nice.fr
Study Locations
-
-
-
Nice, France, 06000
- Recruiting
- CHU de Nice
-
Contact:
- Dominique Donzeau
- Email: donzeau.d@chu-nice.fr
-
Principal Investigator:
- olivier GUERIN, MD
-
Sub-Investigator:
- anne-sophie ROUSSEAU, PU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Olivier GUERIN, MD, Centre Hospitalier Universitaire de Nice
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-PP-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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