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Clinical Trials/NCT06132724
NCT06132724CompletedNot Applicable

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

University Hospital, Grenoble1 site in 1 country20 target enrollmentStarted: December 5, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Database of physiological signals

Study Overview

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.

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
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
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

Outcomes

Primary Outcomes

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

  • Evaluation of the feeling of wearing equipment(15 minutes)
  • Criteria for the observation of a cardiac transition(6 months)
  • Criteria for the observation of a respiratory transition(6 months)
  • Criteria for the observation of a motricity transition(6 months)
  • Multi-modal prediction of the first ventilatory threshold(6 months)

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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