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Completed

NCT Number: NCT06132724

Observation and Interactions Between Cardio-respiratory and Motor Transitions at the Limits of Moderate Exercise.

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Plateforme PRETA P3I

Grenoble, 38043, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Signal acquisition

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of the feeling of wearing equipment

    Time frame: 15 minutes

    Questionnaire at the end of each session to assess the comfort / discomfort wearing the equipment used during the test

  2. Criteria for the observation of a respiratory transition

    Time frame: 6 months

    Feasibility of the transition detection, repeatability of the detection with the respiratory criteria

  3. Criteria for the observation of a cardiac transition

    Time frame: 6 months

    Feasibility of the transition detection, repeatability of the detection with the cardiac criteria

  4. Criteria for the observation of a motricity transition

    Time frame: 6 months

    Feasibility of the transition detection, repeatability of the detection with the motricity criteria

  5. Multi-modal prediction of the first ventilatory threshold

    Time frame: 6 months

    Correlation with the measurement of ventilatory threshold 1 (VT1)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • TIMC-IMAG
  • University Grenoble Alps

Registry information

Official study title

Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices à la frontière de l'Exercice modéré

Acronym: CAREMO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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