AgingACTIFS-AGENCT05413590
Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
A study testing Questionnaires completion, Isometric forces and Energy cost in people with Aging and Fatigue, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Questionnaires completion, Isometric forces and Energy cost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2021to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 35 for the young group, between 65 and 80 for the old group and over 80 for the very old group.
- Signed consent for the study obtained
- Subject affiliated or entitled to a social security scheme
Who cannot join
- Pathology or surgical intervention causing a locomotor disorder
- Neurological, cardiovascular or psychological pathology
- Participants will be excluded if resting or exercise ECG responses show any abnormality, or if resting Heart Rate (HR) > 100 bmp, resting blood pressure > 144 (systolic) / 95 (diastolic) mmHg, pulmonary and or cardiac disease that could affect the health of the participant (arrhythmias and stroke)
- Mini-Mental State Examination score < 20 (>80 years old)
- Significant change in the amount of physical practice over the last 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. The aim of this project is to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.
Read the detailed description
With advancing age, there is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance and increases the likelihood that older people will lose their independence. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. Indeed, recent data support the idea that it is fitness level, not age that explains physiological responses to exercise. However, although there are data about how quickly cardiovascular and neuromuscular functions decline throughout life, less is known on the extent physical activity can help mitigate the loss of these functions. The aim of this project is therefore to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.
- Being tested
- Questionnaires completion, Isometric forces, Energy cost
- Keywords
- cardiovascular function, neuromuscular function, V02max
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires completionOther
Cognitive tests, completing questionnaires, balance test, measuring cardiac variability and post-ischemic hyperemia. Assessments of neuromuscular function on a semi-recumbent ergometric bicycle.
Isometric forcesOther
Measurement of the maximum isometric forces of the knee flexors, the plantar flexors of the ankle and the grip strength of the hand.
Energy costOther
Measurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max.
| Study group | Role | What they receive |
|---|---|---|
| Young, Active group | Active comparator | From 18 to 35 years old.
The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count:
* at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR
* at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR
* At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 Metabolic Equivalent of Task (MET)-minutes per week Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
| Young, sedentary group | Active comparator | From 18 to 35 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
| Old, Active group | Active comparator | From 65 to 80 years old.
The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count:
* at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR
* at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR
* At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
| Old sedentary group | Active comparator | From 65 to 80 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
| Very old, Active group | Active comparator | From 81 years old.
The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count:
* at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR
* at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR
* At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
| Very old sedentary group | Active comparator | From 81 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. Receives: Other: Questionnaires completion; Other: Isometric forces; Other: Energy cost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Measured: At 48 hours
Secondary outcomes (11)
Voluntary activation measurement (%)
The level of voluntary activation will be determined by the force increment obtained following stimulation performed during a condition of the muscle in a state of maximum contraction.
Measured: At 48 hours
Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Measured: At 48 hours
Maximal voluntary contraction (MVC) of the hand grip measurement
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
Measured: At 48 hours
Cardiac variability(ms)
24-hour measurement with an ECG holter for 24 hours.
Measured: At 48 hours
Muscle oxygenation (%)
This is measured by a NIRS20 (near infrared spectroscopy, Oxysoft, Artinis, TheNetherlands)
Measured: At 48 hours
Balance test (s)
This test, performed in unipedal support, consists of asking the subject to hold the unipedal position for as long as possible, on the lower limb of his choice.
Measured: At 48 hours
Test of Get-up-and-Go (s)
For test of Get-up-and-Go, participants will be asked to stand from a seated position, walk 3 meters at their usual pace, turn around, walk back to the chair, and sit down.
Measured in seconds when performing test.
Measured: At 48 hours
Reaction force on the ground for each step (N)
First, a maximum pace walking speed and a comfort speed will be measured in a corridor using photoelectric cells. Then, a biomechanical analysis of walking at several speeds (comfort walking, 2.5, 4 and 5.5 km/h) will be performed on an instrumented treadmill (Treadmetrix, Park City, Utah, United States). This treadmill allows the analysis of the reaction forces on the ground during the strides while controlling the speed of the walk. Each step will last approximately 30 seconds.
Measured: At 72 hours
Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer
Measured: At 72 hours
Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Score from 0 to 52
Measured: At inclusion
Quality of life via the SF-36 questionnaire
This questionnaire is composed of 12 questions representing the eight most relevant domains to describe and evaluate quality of life. Score ranges from 0 to 100, with a higher score defining a more favorable health state.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start30 Nov 2021
- Primary completion23 May 2023
- Study completion6 Jun 2023
Why it stopped: Lack of enrollments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEONARD FEASSON, PHD, Principal investigator, Centre Hospitalier Universitaire de Saint EtienneGuillaume MILLET, PhD, Study chair, UNIVERSITE DE SAINT ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413590
- Sponsor's protocol ID
- 21CH033
- Other IDs
- ANSM
- Acronym
- ACTIFS-AGE
- Status last verified
- Sep 2024
- First submitted
- 10 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luneau E, Rozand V, Murias JM, Millet GY. Effect of Habitual Physical Activity on Strength Loss and Fatigability in Old and Very Old Men. Scand J Med Sci Sports. 2025 Dec;35(12):e70176. doi: 10.1111/sms.70176.
PubMed 41343292
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Physical Activity Effect on Neuromuscular Fatigue of Older People
- ClinicalTrials.gov ID
- NCT05413590
- Acronym / sponsor ID
- ACTIFS-AGE / 21CH033
- Keywords
- cardiovascular function, neuromuscular function, V02max
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollments
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance with advancing age. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. The aim of this project is to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.
Detailed description
With advancing age, there is a decrease in cardiovascular and neuromuscular functions, which leads to reduced performance and increases the likelihood that older people will lose their independence. Physical activity provides health benefits, prevents and treats cardiovascular and neuromuscular disease. Indeed, recent data support the idea that it is fitness level, not age that explains physiological responses to exercise. However, although there are data about how quickly cardiovascular and neuromuscular functions decline throughout life, less is known on the extent physical activity can help mitigate the loss of these functions. The aim of this project is therefore to describe cardiovascular and neuromuscular function in active and sedentary subjects of different ages.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Young, Active group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 18 to 35 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: * at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR * at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR * At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 Metabolic Equivalent of Task (MET)-minutes per week |
| Young, sedentary group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 18 to 35 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. |
| Old, Active group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 65 to 80 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: * at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR * at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR * At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week |
| Old sedentary group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 65 to 80 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. |
| Very old, Active group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 81 years old. The subjects will be considered as active if after completion of the Global Physical Activity Questionnaire (GPAQ), the subjects count: * at least 20 minutes of vigorous physical activity per day for 3 or more days per week OR * at least 30 minutes of moderate physical activity or walking per day for 5 or more days per week OR * At least 5 days of walking and moderate or vigorous physical activity, reaching a minimum of 600 MET-minutes per week |
| Very old sedentary group | Active comparator | Other: Questionnaires completion, Other: Isometric forces, Other: Energy costFrom 81 years old. Subjects who are below these thresholds will be considered as sedentary. To avoid including a subject who recently changed his lifestyle (sedentary becoming active or vice versa), the investigator will ensure the subject kept this physical activity level (expressed using the GPAQ) constant for the last 5 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 35 for the young group, between 65 and 80 for the old group and over 80 for the very old group.
- Signed consent for the study obtained
- Subject affiliated or entitled to a social security scheme
Key exclusion criteria (5 listed)
- Pathology or surgical intervention causing a locomotor disorder
- Neurological, cardiovascular or psychological pathology
- Participants will be excluded if resting or exercise ECG responses show any abnormality, or if resting Heart Rate (HR) > 100 bmp, resting blood pressure > 144 (systolic) / 95 (diastolic) mmHg, pulmonary and or cardiac disease that could affect the health of the participant (arrhythmias and stroke)
- Mini-Mental State Examination score < 20 (>80 years old)
- Significant change in the amount of physical practice over the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires completionCognitive tests, completing questionnaires, balance test, measuring cardiac variability and post-ischemic hyperemia. Assessments of neuromuscular function on a semi-recumbent ergometric bicycle. | Other | Old sedentary group, Old, Active group, Very old sedentary group, Very old, Active group, Young, Active group, Young, sedentary group |
| Isometric forcesMeasurement of the maximum isometric forces of the knee flexors, the plantar flexors of the ankle and the grip strength of the hand. | Other | Old sedentary group, Old, Active group, Very old sedentary group, Very old, Active group, Young, Active group, Young, sedentary group |
| Energy costMeasurement of feet pressure and measurement of the energy cost. Maximum test on an endocycle (classic) to determine VO2max. | Other | Old sedentary group, Old, Active group, Very old sedentary group, Very old, Active group, Young, Active group, Young, sedentary group |
Primary outcome
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement
Time frame: At 48 hours
Maximal isometric force (maximal voluntary contraction, MVC) of the knee extensor muscle measured before and after an incremental test on a bicycle ergometer
11 secondary outcomes
Voluntary activation measurement (%)
Time frame: At 48 hours
Maximal voluntary contraction (MVC) of the plantar flexor muscle measurement
Time frame: At 48 hours
Maximal voluntary contraction (MVC) of the hand grip measurement
Time frame: At 48 hours
Cardiac variability(ms)
Time frame: At 48 hours
Muscle oxygenation (%)
Time frame: At 48 hours
Balance test (s)
Time frame: At 48 hours
Test of Get-up-and-Go (s)
Time frame: At 48 hours
Reaction force on the ground for each step (N)
Time frame: At 72 hours
Maximal oxygen consumption (VO2max) during an effort test on a cycloergometer
Time frame: At 72 hours
Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Time frame: At inclusion
Quality of life via the SF-36 questionnaire
Time frame: At inclusion
Results and safety
The study was stopped early (reason given: Lack of enrollments). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41343292Luneau E, Rozand V, Murias JM, Millet GY. Effect of Habitual Physical Activity on Strength Loss and Fatigability in Old and Very Old Men. Scand J Med Sci Sports. 2025 Dec;35(12):e70176. doi: 10.1111/sms.70176.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEONARD FEASSON, PHD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
Guillaume MILLET, PhD study chair
UNIVERSITE DE SAINT ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires completion, Isometric forces and Energy cost in people with Aging and Fatigue, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollments). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal voluntary contraction (MVC) of the knee extensor muscle measurement (time frame: At 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.