- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07650279
Coherence Breathing Before Cardiopulmonary Exercise Testing
Acute Effects of Coherence Breathing on Cardiopulmonary Exercise Responses in Recreationally Active Adults: A Randomized Crossover Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Slow-paced breathing performed at approximately six breaths per minute has been shown to influence autonomic nervous system activity and heart rate variability. Coherence breathing may improve physiological regulation by enhancing cardiorespiratory synchronization and vagal modulation. However, little is known about whether a brief bout of coherence breathing performed immediately before exercise can influence cardiopulmonary exercise performance. The purpose of this study is to investigate the acute effects of pre-exercise coherence breathing on cardiopulmonary exercise performance and autonomic responses in recreationally active adults. This study will utilize a randomized, counterbalanced crossover design. Recreationally active adults aged 19 to 45 years will complete two experimental conditions in random order separated by a minimum of 48 hours (maximum of 7 days). In one condition, participants will perform 5 minutes of guided coherence breathing using a visual breathing pacer at approximately 6 breaths per minute while seated. In the comparison condition, participants will sit quietly for 5 minutes with spontaneous breathing. Following each condition, participants will complete a standardized treadmill warm-up and a maximal cardiopulmonary exercise test (CPET). Heart rate variability will be assessed during baseline seated rest and during the breathing intervention. Cardiopulmonary variables collected during CPET will include oxygen consumption, heart rate, respiratory responses, and ratings of perceived exertion. Recovery responses over 5 minutes seated include heart rate and blood pressure will also be assessed following exercise.
Findings from this study may improve our understanding of breathing strategies for athletic performance. Specifically, whether slow paced breathing through coherence breathing can serve as a practical autonomic priming strategy before maximal exercise. Moreover, insights from this study may provide insight into the acute interaction between breathing regulation, autonomic function, and exercise responses.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Tamara Rial-Faigenbaum, PhD
- Telefoonnummer: 2159878984
- E-mail: trialfai@monmouth.edu
Studie Contact Back-up
- Naam: Jaime Pigman, PhD
- Telefoonnummer: 732-749-0160
- E-mail: jpigman@monmouth.edu
Studie Locaties
-
-
New Jersey
-
West Long Branch, New Jersey, Verenigde Staten, 07764
- Monmouth University Graduate Center, Human Performance Lab, Room 222
-
Contact:
- Tamara Rial-Faigenbaum, PhD
- Telefoonnummer: 2159878984
- E-mail: trialfai@monmouth.edu
-
Contact:
- Jaime Pigman, PhD
- Telefoonnummer: 732-749-0160
- E-mail: jpigman@monmouth.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Adults aged 19 to 45 years.
- Any biological sex.
- Recreationally active, defined as accumulating at least 3 hours per week of moderate-to-vigorous physical activity.
- Able to perform maximal cardiopulmonary exercise testing on a treadmill.
- Able to provide informed consent.
- Cleared for moderate-to-vigorous physical activity based on the PAR-Q+ (or PAR-Q 2023).
Exclusion Criteria:
- Accumulate less than 3 hours per week of moderate-to-vigorous physical activity.
- Presence of a health condition that contraindicates maximal exercise testing, including:
Cardiovascular disease. Pulmonary disease. Metabolic disorders. Neuromuscular disorders. Orthopedic limitations that impair exercise performance.
- Acute illness that would interfere with participation or exercise testing.
- Inability or unwillingness to complete study procedures.
- Inability or unwillingness to provide informed consent.
- Not cleared for moderate-to-vigorous physical activity based on the PAR-Q+ (or PAR-Q+ 2023).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Coherence Breathing
Participants complete 5 minutes of guided coherence breathing
|
Participants complete 5 minutes of guided coherence breathing which consists or around 6 breathing cycles (5 seconds inhale and 5 seconds exhale)
Andere namen:
|
|
Actieve vergelijker: Spontaneous Breathing
Participants sit quietly for 5 minutes with spontaneous breathing
|
Participants sit quietly for 5 minutes with their regular spontaneous breathing
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Peak Oxygen consumption
Tijdsspanne: during each maximal exercise test immediately after the breathing condition
|
Peak oxygen consumption measured during the maximal cardiopulmonary exercise test (CPET) using a portable metabolic analyzer (Vo2 Master)
|
during each maximal exercise test immediately after the breathing condition
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
rating of perceived exertion (RPE)
Tijdsspanne: measured at baseline, during the exercise test and after recovery
|
using the RPE borg scale (from 1-10)
|
measured at baseline, during the exercise test and after recovery
|
|
Heart Rate Recovery
Tijdsspanne: difference between peak HR during CPET and HR at minute 1, minute 2 and minute 5 of recovery.
|
Heart Rate (bpm) immediately after completing the CPET over a period of 5 minutes
|
difference between peak HR during CPET and HR at minute 1, minute 2 and minute 5 of recovery.
|
|
Time to completion of maximal exercise test
Tijdsspanne: during the exercise test
|
total duration of the exercise test since test starts to voluntary termination
|
during the exercise test
|
|
Peak Heart Rate
Tijdsspanne: measured during the maximal exercise test
|
maximal heart rate achieved during the maximal exercise test
|
measured during the maximal exercise test
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Laborde S, Allen MS, Borges U, Dosseville F, Hosang TJ, Iskra M, Mosley E, Salvotti C, Spolverato L, Zammit N, Javelle F. Effects of voluntary slow breathing on heart rate and heart rate variability: A systematic review and a meta-analysis. Neurosci Biobehav Rev. 2022 Jul;138:104711. doi: 10.1016/j.neubiorev.2022.104711. Epub 2022 May 24.
- Sevoz-Couche C, Laborde S. Heart rate variability and slow-paced breathing:when coherence meets resonance. Neurosci Biobehav Rev. 2022 Apr;135:104576. doi: 10.1016/j.neubiorev.2022.104576. Epub 2022 Feb 12.
- Trinkunas E, Kairiukstiene Z, Trinkunaite M, Poderiene K, Brazdzionyte R, Poderys J. Post-Exercise Controlled Breathing Enhances Cardiovascular Recovery and Autonomic Balance: A Randomised Crossover Study. Medicina (Kaunas). 2026 Feb 3;62(2):318. doi: 10.3390/medicina62020318.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SP2645
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .