HealthyCAREMONCT06132724
Observation and Interactions Between Cardio-respiratory and Motor Transitions at the Limits of Moderate Exercise.
An observational study of Healthy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The goal of this observational study is to learn about physiological transitions around the limit of moderate exercise intensity on cardiac, respiratory and motor modalities, in healthy population. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Signal acquisition
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2023to 11 Jun 2024
- Phase
- Observational
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Heathy volunteers with various physical conditions
Who may be able to join
- Capability to cycle during 20min
- No contraindication to cycling at a moderate pace
- No acute pathology (less than 2 years old)
- No cardiac or respiratory chronic pathology
- No locomotive problem on the spine or the lower limbs
- No recent injuries (less than 2 months)
- Stature compatible with the use of the plethysmography t-shirt
Who cannot join
- Pregnant (urine strip test) or breastfeeding women
- Persons referred to in articles L1121-5 to L1121-8 of the CSP (protected persons) person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Subject being excluded from another study
- Subject who reached the ceiling of 4500 euros due to their participation in other studies involving human in the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices à la frontière de l'Exercice modéré
The goal of this observational study is to learn about physiological transitions around the limit of moderate exercise intensity on cardiac, respiratory and motor modalities, in healthy population.
The main questions it aims to answer is:
- is it possible to define criteria on cardiac, respiratory and motor modalities to identify transitions?
- are those transitions visible on embedded and non-intrusive monitoring equipment?
- are those identified transitions somehow connected to first ventilatory threshold (VT1)?
Participants will do a sub-maximal effort test on cycloergometer calibrated to make them cross their first ventilatory threshold.
Read the detailed description
Cycling is a commonly prescribed activity when it comes to physical activities for rehabilitation. Because it is soft and progressive effort, cycling suits well for patients with chronic conditions (diabete, cancer, fibromyalgia, ...) For safety and effectiveness of the activity, it is necessary to prescribe activity at a regular and moderate intensity. This can be achieved by personalizing intensities to match specifically the patient health condition in order to build an efficient and progressive rehabilitation program.
Physical activity prescription rely on four pillars: frequency, duration, volume and intensity. While first three pillars are quite easy to regulate,effort intensity is harder to handle on training planning. It is harder to measure, and defining personalized guideline for practice is more complex.
It is known that first ventilatory threshold (VT1) is a individualized marker representing the higher limit of moderate intensity effort zone. It makes it an interesting tool for the prescription of intensity for retraining purposes: it guaranties a safe practice, intense enough to make beneficial physiological adaptations for the patient.
In this retraining context and with this study, we aim to identify markers of this transition on cardiac, respiratory and motor modalities, with embedded and non intrusive equipment, during a sub-maximal effort test in laboratory.
- Conditions
- Healthy
- Being tested
- Signal acquisition
- Keywords
- Retraining, Physical Activity, First Ventilatory Threshold, Moderate Intensity Domain, Physiological Transitions, Motricity, Cardiorespiratory, Connected Objects
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Signal acquisitionOther
Synchronized signals from cardiac, respiratory and movements non invasive measurements.
One acquisition is 20 minutes long, and each subject participate to two sessions, separated by 1 to 15 days.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Subjects who will agree to participate to the study will be healthy subject with no particular antecedents.
Subjects will be enroled for two sessions with a 20 min monitoring phase in each session, to coect physiological data with non invasive sensors. Receives: Other: Signal acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of physiological signals
Synchronized signals from embedded and non-intrusive connected devices for cardiorespiratory and motricity measurements and equivalent laboratory measurements during cycling on a cyclo-ergometer
Measured: 20 minutes
Secondary outcomes (5)
Evaluation of the feeling of wearing equipment
Questionnaire at the end of each session to assess the comfort / discomfort wearing the equipment used during the test
Measured: 15 minutes
Criteria for the observation of a respiratory transition
Feasibility of the transition detection, repeatability of the detection with the respiratory criteria
Measured: 6 months
Criteria for the observation of a cardiac transition
Feasibility of the transition detection, repeatability of the detection with the cardiac criteria
Measured: 6 months
Criteria for the observation of a motricity transition
Feasibility of the transition detection, repeatability of the detection with the motricity criteria
Measured: 6 months
Multi-modal prediction of the first ventilatory threshold
Correlation with the measurement of ventilatory threshold 1 (VT1)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start5 Dec 2023
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, University Grenoble Alps
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132724
- Sponsor's protocol ID
- 38RC23.0263
- Acronym
- CAREMO
- Status last verified
- Mar 2025
- First submitted
- 9 Nov 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blair SN. Physical inactivity: the biggest public health problem of the 21st century. Br J Sports Med. 2009 Jan;43(1):1-2. No abstract available.
PubMed 19136507Pisot R. Physical Inactivity - the Human Health's Greatest Enemy. Zdr Varst. 2021 Dec 27;61(1):1-5. doi: 10.2478/sjph-2022-0002. eCollection 2022 Mar.
PubMed 35111260Meyler S, Bottoms L, Muniz-Pumares D. Biological and methodological factors affecting V̇O2max response variability to endurance training and the influence of exercise intensity prescription. Exp Physiol. 2021 Jul;106(7):1410-1424. doi: 10.1113/EP089565. Epub 2021 Jun 8.
PubMed 34036650Succi PJ, Dinyer TK, Byrd MT, Bergstrom HC. Comparisons of the Metabolic Intensities at Heart Rate, Gas Exchange, and Ventilatory Thresholds. Int J Exerc Sci. 2020 May 1;13(2):455-469. doi: 10.70252/IBRC8606. eCollection 2020.
PubMed 32509109Pouliquen C, Nicolas G, Bideau B, Garo G, Megret A, Delamarche P, Bideau N. Spatiotemporal analysis of 3D kinematic asymmetry in professional cycling during an incremental test to exhaustion. J Sports Sci. 2018 Oct;36(19):2155-2163. doi: 10.1080/02640414.2018.1432066. Epub 2018 Jan 30.
PubMed 29381424Jamnick NA, Pettitt RW, Granata C, Pyne DB, Bishop DJ. An Examination and Critique of Current Methods to Determine Exercise Intensity. Sports Med. 2020 Oct;50(10):1729-1756. doi: 10.1007/s40279-020-01322-8.
PubMed 32729096
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices à la frontière de l'Exercice modéré
- ClinicalTrials.gov ID
- NCT06132724
- Acronym / sponsor ID
- CAREMO / 38RC23.0263
- Conditions
- Healthy
- Keywords
- Retraining, Physical Activity, First Ventilatory Threshold, Moderate Intensity Domain, Physiological Transitions, Motricity, Cardiorespiratory, Connected Objects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- TIMC-IMAG, University Grenoble Alps
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 15 Nov 2023 (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.
The goal of this observational study is to learn about physiological transitions around the limit of moderate exercise intensity on cardiac, respiratory and motor modalities, in healthy population.
The main questions it aims to answer is:
- is it possible to define criteria on cardiac, respiratory and motor modalities to identify transitions?
- are those transitions visible on embedded and non-intrusive monitoring equipment?
- are those identified transitions somehow connected to first ventilatory threshold (VT1)?
Participants will do a sub-maximal effort test on cycloergometer calibrated to make them cross their first ventilatory threshold.
Detailed description
Cycling is a commonly prescribed activity when it comes to physical activities for rehabilitation. Because it is soft and progressive effort, cycling suits well for patients with chronic conditions (diabete, cancer, fibromyalgia, ...) For safety and effectiveness of the activity, it is necessary to prescribe activity at a regular and moderate intensity. This can be achieved by personalizing intensities to match specifically the patient health condition in order to build an efficient and progressive rehabilitation program.
Physical activity prescription rely on four pillars: frequency, duration, volume and intensity. While first three pillars are quite easy to regulate,effort intensity is harder to handle on training planning. It is harder to measure, and defining personalized guideline for practice is more complex.
It is known that first ventilatory threshold (VT1) is a individualized marker representing the higher limit of moderate intensity effort zone. It makes it an interesting tool for the prescription of intensity for retraining purposes: it guaranties a safe practice, intense enough to make beneficial physiological adaptations for the patient.
In this retraining context and with this study, we aim to identify markers of this transition on cardiac, respiratory and motor modalities, with embedded and non intrusive equipment, during a sub-maximal effort test in laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Signal acquisitionSubjects who will agree to participate to the study will be healthy subject with no particular antecedents. Subjects will be enroled for two sessions with a 20 min monitoring phase in each session, to coect physiological data with non invasive sensors. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Heathy volunteers with various physical conditions
Key inclusion criteria (7 listed)
- Capability to cycle during 20min
- No contraindication to cycling at a moderate pace
- No acute pathology (less than 2 years old)
- No cardiac or respiratory chronic pathology
- No locomotive problem on the spine or the lower limbs
Key exclusion criteria (4 listed)
- Pregnant (urine strip test) or breastfeeding women
- Persons referred to in articles L1121-5 to L1121-8 of the CSP (protected persons) person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
- Subject being excluded from another study
- Subject who reached the ceiling of 4500 euros due to their participation in other studies involving human in the past 12 months
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 |
|---|---|---|
| Signal acquisitionSynchronized signals from cardiac, respiratory and movements non invasive measurements. One acquisition is 20 minutes long, and each subject participate to two sessions, separated by 1 to 15 days. | Other | Healthy Volunteers |
Primary outcome
Database of physiological signals
Time frame: 20 minutes
Synchronized signals from embedded and non-intrusive connected devices for cardiorespiratory and motricity measurements and equivalent laboratory measurements during cycling on a cyclo-ergometer
5 secondary outcomes
Evaluation of the feeling of wearing equipment
Time frame: 15 minutes
Criteria for the observation of a respiratory transition
Time frame: 6 months
Criteria for the observation of a cardiac transition
Time frame: 6 months
Criteria for the observation of a motricity transition
Time frame: 6 months
Multi-modal prediction of the first ventilatory threshold
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 19136507Blair SN. Physical inactivity: the biggest public health problem of the 21st century. Br J Sports Med. 2009 Jan;43(1):1-2. No abstract available.
- Background: PubMed 35111260Pisot R. Physical Inactivity - the Human Health's Greatest Enemy. Zdr Varst. 2021 Dec 27;61(1):1-5. doi: 10.2478/sjph-2022-0002. eCollection 2022 Mar.
- Background: PubMed 34036650Meyler S, Bottoms L, Muniz-Pumares D. Biological and methodological factors affecting V̇O2max response variability to endurance training and the influence of exercise intensity prescription. Exp Physiol. 2021 Jul;106(7):1410-1424. doi: 10.1113/EP089565. Epub 2021 Jun 8.
- Background: PubMed 32509109Succi PJ, Dinyer TK, Byrd MT, Bergstrom HC. Comparisons of the Metabolic Intensities at Heart Rate, Gas Exchange, and Ventilatory Thresholds. Int J Exerc Sci. 2020 May 1;13(2):455-469. doi: 10.70252/IBRC8606. eCollection 2020.
- Background: PubMed 29381424Pouliquen C, Nicolas G, Bideau B, Garo G, Megret A, Delamarche P, Bideau N. Spatiotemporal analysis of 3D kinematic asymmetry in professional cycling during an incremental test to exhaustion. J Sports Sci. 2018 Oct;36(19):2155-2163. doi: 10.1080/02640414.2018.1432066. Epub 2018 Jan 30.
- Background: PubMed 32729096Jamnick NA, Pettitt RW, Granata C, Pyne DB, Bishop DJ. An Examination and Critique of Current Methods to Determine Exercise Intensity. Sports Med. 2020 Oct;50(10):1729-1756. doi: 10.1007/s40279-020-01322-8.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University Hospital, Grenoble 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 1 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Database of physiological signals (time frame: 20 minutes). 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 NCT06132724, which also lists 6 linked publications.
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 1 Apr 2025.