Clinical trial NCT06132724: Observation and Interactions Between Cardio-respiratory and Motor Transitions at the Limits of Moderate Exercise.
Official title: Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices à la frontière de l'Exercice modéré
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Retraining
Physical Activity
First Ventilatory Threshold
Moderate Intensity Domain
Physiological Transitions
Motricity
Cardiorespiratory
Connected Objects
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: TIMC-IMAG
name: University Grenoble Alps
First posted: 2023-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heathy volunteers with various physical conditions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Database of physiological signals
timeFrame: 20 minutes
Secondary outcomes:
measure: Evaluation of the feeling of wearing equipment
timeFrame: 15 minutes
measure: Criteria for the observation of a respiratory transition
timeFrame: 6 months
measure: Criteria for the observation of a cardiac transition
timeFrame: 6 months
measure: Criteria for the observation of a motricity transition
timeFrame: 6 months
measure: Multi-modal prediction of the first ventilatory threshold
timeFrame: 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Plateforme PRETA P3I
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.