NCT06132724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

November 9, 2023

Last Update Submit

March 26, 2025

Conditions

Keywords

RetrainingPhysical ActivityFirst Ventilatory ThresholdModerate Intensity DomainPhysiological TransitionsMotricityCardiorespiratoryConnected Objects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Evaluation of the feeling of wearing equipment

    15 minutes

  • Criteria for the observation of a respiratory transition

    6 months

  • Criteria for the observation of a cardiac transition

    6 months

  • Criteria for the observation of a motricity transition

    6 months

  • Multi-modal prediction of the first ventilatory threshold

    6 months

Study Arms (1)

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

Interventions

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.

Healthy Volunteers

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Heathy volunteers with various physical conditions

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plateforme PRETA P3I

Grenoble, 38043, France

Location

Related 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.

    PMID: 19136507BACKGROUND
  • 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.

    PMID: 35111260BACKGROUND
  • 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.

    PMID: 34036650BACKGROUND
  • 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.

    PMID: 32509109BACKGROUND
  • 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.

    PMID: 29381424BACKGROUND
  • 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.

    PMID: 32729096BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 15, 2023

Study Start

December 5, 2023

Primary Completion

June 11, 2024

Study Completion

June 11, 2024

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations