- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07928713
Observation and Interactions Between Cardio-respiratory and Motor Transitions During Maximal Incremental Exercise Test on Elliptical Bike and Running Treadmill.
Observation et Mise en Relation Des Transitions Cardio-respiratoires et Motrices Lors d'un Exercice incrémental Maximal.
For safety considerations and to ensure the effectiveness of physical activity within a rehabilitation programme, it is important to establish an appropriate exercise intensity to achieve the programme's objectives. This requires identifying individualised exercise intensity zones that are specifically tailored to each patient, in order to design an effective and progressive exercise training programme.
Exercise prescription is based on four principles: frequency, duration, volume, and intensity. The first three factors are relatively easy to adjust when planning a training programme, whereas exercise intensity is based on a concept that is more difficult to assess and control. On the one hand, exercise intensity is more complex to measure; on the other, establishing individualised reference points and guidelines tailored to each patient is not straightforward.
It is now well established that ventilatory transitions are individualised physiological markers that delineate exercise intensity zones. These transition markers provide valuable reference points for exercise training, helping to ensure that physical activity is both safe and sufficiently intense to induce beneficial physiological adaptations in patients.
Within this rehabilitation context, the aim of the present study is to identify markers of these two physiological transitions during a maximal exercise test conducted under laboratory conditions. The study seeks to identify non-invasive markers related to cardiovascular, respiratory, and motor responses, with a view to conducting similar assessments under real-world conditions in the future. A database has already been established using cycle ergometry (the CAREMO protocol). The next step is to build a new database based on maximal exercise testing, this time using two different exercise modalities: the elliptical trainer and the treadmill. In addition to the new challenge of investigating the second ventilatory transition, the less constrained movement patterns associated with these exercise modalities require adaptations to the analysis methods in order to continue identifying changes in motor behaviour.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
There are currently no accessible physiological datasets combining synchronised motor data (motion analysis) and cardiorespiratory data (ECG, gas exchange analysis, and spirometry) in humans during exercise on an elliptical trainer or a treadmill.
The work conducted as part of this study will focus on acquiring data from wearable inertial measurement units (IMUs) to assess motor behaviour, cardiac measurements, and laboratory measurements required to determine the first and second ventilatory thresholds (VT1 and VT2) using gas exchange analysis, across both exercise modalities.
To this end, 20 participants will take part in two sessions involving a maximal incremental exercise test. The two sessions will be scheduled between one and fifteen days apart. The first session will involve exercise on a treadmill, while the second will involve exercise on an elliptical trainer.
The signals recorded during the study may contribute to a better understanding of the relationship between cardiorespiratory physiology and motor behaviour during exercise.
For example, as outlined in the secondary objectives of the study, these signals may be used to develop new algorithms for defining criteria to assess motor transitions.
The following hypotheses will be investigated:
- This study will enable the creation of a database containing synchronised, non-invasive cardiorespiratory and motor behaviour signals.
- The questionnaire will allow the assessment of differences in the impact of each piece of exercise equipment on participants' comfort during exercise.
- The database will enable the analysis of relationships between motor and cardiorespiratory data during physical activity, particularly as participants cross the two physiological thresholds (VT1 and VT2).
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Vianney POIRON, PhD
- Telefonní číslo: +33 6 77 15 98 45
- E-mail: vianney.poiron@univ-grenoble-alpes.fr
Studijní záloha kontaktů
- Jméno: Stéphane Doutreleau, Cardiologist
- Telefonní číslo: +33 6 72 51 16 56
- E-mail: sdoutreleau@chu-grenoble.fr
Studijní místa
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Grenoble, Francie, 38043
- CHU Grenoble Alpes - Hopital Sud
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Kontakt:
- Stéphane DOUTRELEAU, Cardiologist
- Telefonní číslo: +3376767575
- E-mail: sdoutreleau@chu-grenoble.fr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Healthy volunteers
Popis
Inclusion Criteria:
- Men and women of 18 to 64 y-old
- Subject able to run on a treadmill and bike on an elliptical bike for 20minutes
- No contraindications to participating in physical exercise.
- No chronic cardiac or respiratory conditions.
- No locomotor disorders affecting the spine or lower limbs that are incompatible with physical activity.
- No recent injuries (within the previous two months) that would prevent participation in physical activity.
- Affiliation with a social security scheme.
Exclusion Criteria:
- Pregnant women (as determined by a urine pregnancy test) and breastfeeding women.
- Use of medication likely to significantly interfere with heart rate regulation, as assessed by the principal investigator.
- Individuals falling within the categories specified in Articles L. 1121-5 to L. 1121-8 of the French Public Health Code (Code de la santé publique). These include protected individuals, namely pregnant women, women in labour, breastfeeding mothers, individuals deprived of their liberty by judicial or administrative decision, individuals receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8, individuals admitted to a healthcare or social care facility for purposes other than research, minors, and individuals subject to a legal protection measure or unable to express their consent.
- Personnel who have a hierarchical relationship with the principal investigator.
- Individuals currently subject to an exclusion period from another study.
- Individuals who would receive more than €6,000 in compensation for their participation in other research involving human participants during the 12 months preceding this study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Zdraví dobrovolníci
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Incremental exercise tests on treadmill Incremental exercise tests on elliptical bike |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Inertial Measurement Units
Časové okno: 20 minutes of exercise test
|
Measured with Inertial Measurement Units (IMU), placed on the pelvis, the thighs and the shanks. Time series collected at 60Hz, with 3 axis Accelerations (m/s²), 3 axis Gyroscops (rad/s) Data are timestamped and synchronized with the world clock |
20 minutes of exercise test
|
|
Gas Analysis
Časové okno: 20 minutes of exercise test
|
Gas analyser measurements, (VO2 (L/min), VCO2 (L/min), PetO2 (mmHg), PetCO2 (mmHg), VE (L/min) Measures are timestamped, and saved breath-by-breath Data are timestamped and synchronized with the world clock |
20 minutes of exercise test
|
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Rate of Perceived Exertion (RPE)
Časové okno: 20 minutes of exercise test
|
RPE, also named BORG scale rates perceived exertion on a scale from 6 to 20. 1 measurement per min Data are timestamped and synchronized with the world clock |
20 minutes of exercise test
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Ergometer
Časové okno: 20 minutes of exercise test
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Running Treadmill, or Elliptical bike Data collected are the following (1Hz): Cadence, Human Power or Speed Data are timestamped and synchronized with the world clock |
20 minutes of exercise test
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- Rogers B, Giles D, Draper N, Hoos O, Gronwald T. A New Detection Method Defining the Aerobic Threshold for Endurance Exercise and Training Prescription Based on Fractal Correlation Properties of Heart Rate Variability. Front Physiol. 2021 Jan 15;11:596567. doi: 10.3389/fphys.2020.596567. eCollection 2020.
- Villard S, Casties JF, Mottet D. Dynamic stability of locomotor respiratory coupling during cycling in humans. Neurosci Lett. 2005 Aug 5;383(3):333-8. doi: 10.1016/j.neulet.2005.04.047.
- Cassirame J, Eustache E, Garbellotto L, Chevrolat S, Gimenez P, Lepretre PM. Detrended fluctuation analysis to determine physiologic thresholds, investigation and evidence from incremental cycling test. Eur J Appl Physiol. 2025 Feb;125(2):523-533. doi: 10.1007/s00421-024-05614-z. Epub 2024 Sep 28.
- Keir DA, Iannetta D, Mattioni Maturana F, Kowalchuk JM, Murias JM. Identification of Non-Invasive Exercise Thresholds: Methods, Strategies, and an Online App. Sports Med. 2022 Feb;52(2):237-255. doi: 10.1007/s40279-021-01581-z. Epub 2021 Oct 25.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 38RC26.0237 CAREMOMAX
Plán pro data jednotlivých účastníků (IPD)
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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