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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06132724

Collaborator

TIMC-IMAG (Other), University Grenoble Alps (Other)

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Database of physiological signals [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 Outcome Measures

Evaluation of the feeling of wearing equipment [15 minutes]
Questionnaire at the end of each session to assess the comfort / discomfort wearing the equipment used during the test
Criteria for the observation of a respiratory transition [6 months]
Feasibility of the transition detection, repeatability of the detection with the respiratory criteria
Criteria for the observation of a cardiac transition [6 months]
Feasibility of the transition detection, repeatability of the detection with the cardiac criteria
Criteria for the observation of a motricity transition [6 months]
Feasibility of the transition detection, repeatability of the detection with the motricity criteria
Multi-modal prediction of the first ventilatory threshold [6 months]
Correlation with the measurement of ventilatory threshold 1 (VT1)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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