Clinical trial NCT06692543: Sedentary or Exercised : Neuromuscular and Immunometabolic Observations and Retrospection
Official title: Immunometabolic and Neuromuscular Markers of Vitality Capacity : SENIOR Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Keywords: immunity
aging
muscles
exercise
metabolism
physical activity
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: LAMHESS
name: Institut de bilogie de Valrose
name: INSERM-C3M
name: LP2M
First posted: 2024-11-18
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2x20 people aged \>55 yo, 1 group physically active, the other is physically inactive
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: * 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

Primary outcomes:
measure: Difference of T cell metabolism between active and inactive participants
timeFrame: at day 0
measure: Difference of T cell metabolism between active and inactive participants
timeFrame: at day 0
Secondary outcomes:
measure: WHOQOLD-OLD Questionnaire
timeFrame: at day 0
measure: Capacity vitality
timeFrame: at day 0 and 14
measure: Neuromuscular parameters
timeFrame: at day 0 and 14
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Olivier GUERIN, MD
role: PRINCIPAL_INVESTIGATOR
References: