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

Healthy Clinical Trial

— CAREMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132724
• Other study ID #: 38RC23.0263
• Status: Recruiting
• Start date: December 5, 2023
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Grenoble
• Contact: François BOUCHER
• Phone: +33476637117
• Email: francois.boucher[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
France	Plateforme PRETA P3I	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	TIMC-IMAG, University Grenoble Alps

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View 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. — View Citation

Meyler S, Bottoms L, Muniz-Pumares D. Biological and methodological factors affecting V?O2max 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. — View 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. — View 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. — View 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. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Criteria for the observation of a respiratory transition	Feasibility of the transition detection, repeatability of the detection with the respiratory criteria	6 months
Secondary	Criteria for the observation of a cardiac transition	Feasibility of the transition detection, repeatability of the detection with the cardiac criteria	6 months
Secondary	Criteria for the observation of a motricity transition	Feasibility of the transition detection, repeatability of the detection with the motricity criteria	6 months
Secondary	Multi-modal prediction of the first ventilatory threshold	Correlation with the measurement of ventilatory threshold 1 (VT1)	6 months