Observation and Interactions Between Cardio-respiratory and Motor Transitions During Maximal Incremental Exercise Test on Elliptical Bike and Running Treadmill.

November 4, 2026 updated by: University Hospital, Grenoble

Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices Lors d'un Exercice incrémental Maximal.

For safety considerations and to ensure the effectiveness of physical activity within a rehabilitation programme, it is important to establish an appropriate exercise intensity to achieve the programme's objectives. This requires identifying individualised exercise intensity zones that are specifically tailored to each patient, in order to design an effective and progressive exercise training programme.

Exercise prescription is based on four principles: frequency, duration, volume, and intensity. The first three factors are relatively easy to adjust when planning a training programme, whereas exercise intensity is based on a concept that is more difficult to assess and control. On the one hand, exercise intensity is more complex to measure; on the other, establishing individualised reference points and guidelines tailored to each patient is not straightforward.

It is now well established that ventilatory transitions are individualised physiological markers that delineate exercise intensity zones. These transition markers provide valuable reference points for exercise training, helping to ensure that physical activity is both safe and sufficiently intense to induce beneficial physiological adaptations in patients.

Within this rehabilitation context, the aim of the present study is to identify markers of these two physiological transitions during a maximal exercise test conducted under laboratory conditions. The study seeks to identify non-invasive markers related to cardiovascular, respiratory, and motor responses, with a view to conducting similar assessments under real-world conditions in the future. A database has already been established using cycle ergometry (the CAREMO protocol). The next step is to build a new database based on maximal exercise testing, this time using two different exercise modalities: the elliptical trainer and the treadmill. In addition to the new challenge of investigating the second ventilatory transition, the less constrained movement patterns associated with these exercise modalities require adaptations to the analysis methods in order to continue identifying changes in motor behaviour.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There are currently no accessible physiological datasets combining synchronised motor data (motion analysis) and cardiorespiratory data (ECG, gas exchange analysis, and spirometry) in humans during exercise on an elliptical trainer or a treadmill.

The work conducted as part of this study will focus on acquiring data from wearable inertial measurement units (IMUs) to assess motor behaviour, cardiac measurements, and laboratory measurements required to determine the first and second ventilatory thresholds (VT1 and VT2) using gas exchange analysis, across both exercise modalities.

To this end, 20 participants will take part in two sessions involving a maximal incremental exercise test. The two sessions will be scheduled between one and fifteen days apart. The first session will involve exercise on a treadmill, while the second will involve exercise on an elliptical trainer.

The signals recorded during the study may contribute to a better understanding of the relationship between cardiorespiratory physiology and motor behaviour during exercise.

For example, as outlined in the secondary objectives of the study, these signals may be used to develop new algorithms for defining criteria to assess motor transitions.

The following hypotheses will be investigated:

  • This study will enable the creation of a database containing synchronised, non-invasive cardiorespiratory and motor behaviour signals.
  • The questionnaire will allow the assessment of differences in the impact of each piece of exercise equipment on participants' comfort during exercise.
  • The database will enable the analysis of relationships between motor and cardiorespiratory data during physical activity, particularly as participants cross the two physiological thresholds (VT1 and VT2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • CHU Grenoble Alpes - Hopital Sud
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

Inclusion Criteria:

  • Men and women of 18 to 64 y-old
  • Subject able to run on a treadmill and bike on an elliptical bike for 20minutes
  • No contraindications to participating in physical exercise.
  • No chronic cardiac or respiratory conditions.
  • No locomotor disorders affecting the spine or lower limbs that are incompatible with physical activity.
  • No recent injuries (within the previous two months) that would prevent participation in physical activity.
  • Affiliation with a social security scheme.

Exclusion Criteria:

  • Pregnant women (as determined by a urine pregnancy test) and breastfeeding women.
  • Use of medication likely to significantly interfere with heart rate regulation, as assessed by the principal investigator.
  • Individuals falling within the categories specified in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code (Code de la santé publique). These include protected individuals, namely pregnant women, women in labour, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, individuals receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, individuals admitted to a healthcare or social care facility for purposes other than research, minors, and individuals subject to a legal protection measure or unable to express their consent.
  • Personnel who have a hierarchical relationship with the principal investigator.
  • Individuals currently subject to an exclusion period from another study.
  • Individuals who would receive more than €6,000 in compensation for their participation in other research involving human participants during the 12 months preceding this study.

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

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy volunteers
Other: Treadmill

Incremental exercise tests on treadmill

Other: Elliptical bike

Incremental exercise tests on elliptical bike

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inertial Measurement Units
Time Frame: 20 minutes of exercise test

Measured with Inertial Measurement Units (IMU), placed on the pelvis, the thighs and the shanks.

Time series collected at 60Hz, with 3 axis Accelerations (m/s²), 3 axis Gyroscops (rad/s) Data are timestamped and synchronized with the world clock
20 minutes of exercise test
Gas Analysis
Time Frame: 20 minutes of exercise test

Gas analyser measurements, (VO2 (L/min), VCO2 (L/min), PetO2 (mmHg), PetCO2 (mmHg), VE (L/min) Measures are timestamped, and saved breath-by-breath Data are timestamped and synchronized with the world clock
20 minutes of exercise test
Rate of Perceived Exertion (RPE)
Time Frame: 20 minutes of exercise test

RPE, also named BORG scale rates perceived exertion on a scale from 6 to 20.

1 measurement per min Data are timestamped and synchronized with the world clock
20 minutes of exercise test
Ergometer
Time Frame: 20 minutes of exercise test

Running Treadmill, or Elliptical bike

Data collected are the following (1Hz):

Cadence, Human Power or Speed Data are timestamped and synchronized with the world clock
20 minutes of exercise test

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TIMC-IMAG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC26.0237 CAREMOMAX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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