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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Signal acquisition

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Plateforme PRETA P3I

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Heathy volunteers with various physical conditions

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Signal acquisition; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	15 minutes
Criteria for the observation of a respiratory transition	Feasibility of the transition detection, repeatability of the detection with the respiratory criteria	6 months
Criteria for the observation of a cardiac transition	Feasibility of the transition detection, repeatability of the detection with the cardiac criteria	6 months
Criteria for the observation of a motricity transition	Feasibility of the transition detection, repeatability of the detection with the motricity criteria	6 months
Multi-modal prediction of the first ventilatory threshold	Correlation with the measurement of ventilatory threshold 1 (VT1)	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Grenoble Alps; TIMC-IMAG

Publications and helpful links

General 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.
• Pisot 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.
• Meyler 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.
• Pouliquen 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.
• Jamnick 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.
• Succi 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): June 11, 2024
• Study Completion (Actual): June 11, 2024

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Cardiorespiratory; Retraining; Motricity; First Ventilatory Threshold; Moderate Intensity Domain; Physiological Transitions; Connected Objects
• Other Study ID Numbers: 38RC23.0263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No