- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07608887
Effect of Hot Spring Therapy on Autonomic Nervous System and Exercise Performance During Altitude Training
23 juin 2026 mis à jour par: Ziyue Ou, Macao Polytechnic University
A Randomized Controlled Trial to Investigate the Effects of Balneotherapy on Cardiac Autonomic Regulation and Exercise Performance in Healthy Adolescents Undergoing Real 1600-meter Altitude Training and Athlete Training.
This randomized controlled trial aims to investigate the effects of balneotherapy (hot spring bathing) on cardiac autonomic nervous system function and exercise performance in healthy athletes undergoing high-altitude training.
Participants will be randomly assigned to the intervention group (receiving hot spring baths three times per week (38°C, 20 minutes) combined with high-altitude training), the control group (receiving routine recovery protocols combined with high-altitude training), or the hot water immersion group (receiving hot water baths three times per week (38°C, 20 minutes) combined with high-altitude training).
Primary outcome measures include heart rate variability (HRV) indices and exercise performance indicators.
Secondary outcomes include blood lactate, peripheral oxygen saturation (SpO2), and subjective fatigue.
These findings may provide evidence for non-pharmacological interventions to enhance high-altitude training adaptation and exercise recovery.
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
27
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Macao, Chine
- Macao Polytechnic University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Male or female aged 11-17years
- Regular endurance training (≥3 sessions/week) for ≥2 years
- No history of altitude exposure >2000m in the past 3 months
- No contraindications to hot water immersion (e.g., uncontrolled hypertension, severe cardiovascular disease, open wounds, pregnancy)
- Ability to provide written informed consent- Willingness to abstain from other recovery modalities (e.g., massage, cryotherapy, compression garments) during the study period
Exclusion Criteria:
- History of cardiovascular, respiratory, renal, or endocrine disorders
- Current use of medications affecting autonomic function (e.g., beta-blockers, anticholinergics)- History of syncope or heat intolerance
- Acute musculoskeletal injury within the past 6 months- Regular use of sauna, hot tub, or spa within the past month
- Pregnancy or breastfeeding (for female participants)- Shift work or trans-meridian travel within 2 weeks prior to baseline assessment
- Alcohol consumption >14 units/week or smoking
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Natural Recovery Group
Control group participants will undergo the same altitude training protocol (altitude 1600 meters) for 4 weeks.
After each training session, participants will receive standard recovery procedures, including 20 minutes of passive rest in a thermoneutral environment (room temperature 24°C), supplemented with mild hydration and self-selected stretching.
No hydrothermal intervention will be provided.
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Control group participants will undergo the same altitude training protocol (altitude 1600 meters) for 4 weeks.
After each training session, participants will receive standard recovery procedures, including 20 minutes of passive rest in a thermoneutral environment (room temperature 24°C), supplemented with mild hydration and self-selected stretching.
No hydrothermal intervention will be provided.
Autres noms:
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Comparateur actif: Hot water immersion group
The hot water immersion group will undergo a 4-week altitude training at 1600 meters above sea level.
Subjects will receive a 20-minute hot water immersion (daily tap water, 38°C±1°C) in a standardized indoor hot spring facility.
The immersion protocol involves soaking the body below the chest for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
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The hot water immersion group will undergo a 4-week altitude training at 1600 meters above sea level.
Subjects will receive a 20-minute hot water immersion (daily tap water, 38°C±1°C) in a standardized indoor hot spring facility.
The immersion protocol involves soaking the body below the chest for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
Autres noms:
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Expérimental: Hot Spring Immersion Group
The hot spring immersion group will undergo a 4-week high-altitude training at an altitude of 1600 meters.
Subjects will receive a 20-minute hot spring therapy (natural hot spring water, 38°C ± 1°C) in a standardized indoor hot spring facility.
The immersion protocol involves soaking the body below the chest for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
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The hot spring immersion group will undergo a 4-week high-altitude training at an altitude of 1600 meters.
Subjects will receive a 20-minute hot spring therapy (natural hot spring water, 38°C ± 1°C) in a standardized indoor hot spring facility.
The immersion protocol involves soaking the body below the chest for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Heart Rate Variability (HRV) - RMSSD
Délai: Baselines were measured at the formal start of the experiment, at night during the 2nd, 3rd, and 4th weeks (post-intervention) after ascending the plateau, and post-tests were conducted one week after descending the plateau.
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Root mean square of successive differences (RMSSD) between normal heartbeats, measured from a 5-minute seated ECG recording in a quiet, temperature-controlled (22-24°C) room after 15 minutes of rest.
A higher RMSSD value indicates stronger parasympathetic activity.
Unit: milliseconds (ms).
Baseline, Week 2, Week 3 (post-intervention).
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Baselines were measured at the formal start of the experiment, at night during the 2nd, 3rd, and 4th weeks (post-intervention) after ascending the plateau, and post-tests were conducted one week after descending the plateau.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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HRV - SDNN
Délai: Baselines were measured at the formal start of the experiment, at night during the 2nd, 3rd, and 4th weeks (post-intervention) after ascending the plateau, and post-tests were conducted one week after descending the plateau.
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Standard deviation of NN intervals (normal-to-normal R-R intervals), reflecting overall autonomic modulation.
Unit: milliseconds (ms).
Baseline, Week 2, Week 3, Week4, post-tests
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Baselines were measured at the formal start of the experiment, at night during the 2nd, 3rd, and 4th weeks (post-intervention) after ascending the plateau, and post-tests were conducted one week after descending the plateau.
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Peripheral Oxygen Saturation (SpO2)
Délai: one month.
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Resting peripheral oxygen saturation measured via fingertip pulse oximeter after 10 minutes of seated rest.
Unit: percentage (%)
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one month.
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Rating of Perceived Exertion (RPE)
Délai: one month.
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Borg 6-20 scale rating of perceived exertion recorded immediately after each training session.
Higher scores indicate greater subjective effort.
Unit: score (6-20).
Daily during intervention
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one month.
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Maximum oxygen uptake
Délai: The baseline measurement was taken before the official start of the experiment, and the post-test was conducted one week after descending from the plateau.
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Testing maximum oxygen uptake on a rowing ergometer combined with a cardiopulmonary function tester.
Protocol: Using a graded incremental protocol to test maximal oxygen uptake (VO2max).
Units: mL·kg-1 ·min-1.
Baseline, Week 5.
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The baseline measurement was taken before the official start of the experiment, and the post-test was conducted one week after descending from the plateau.
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30-second anaerobic power.
Délai: The tests are scheduled before entering the plateau (baseline), during the 4th week of plateau training, and 1 week after leaving the plateau.
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Perform a 30-s all-out test on a rowing ergometer.
Protocol: sprint at maximum effort to measure the 30-second average power.
Record power.
Units: watt.
Baseline, Week 4,1 week after altitude training.
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The tests are scheduled before entering the plateau (baseline), during the 4th week of plateau training, and 1 week after leaving the plateau.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Laukkanen T, Khan H, Zaccardi F, Laukkanen JA. Association between sauna bathing and fatal cardiovascular and all-cause mortality events. JAMA Intern Med. 2015 Apr;175(4):542-8. doi: 10.1001/jamainternmed.2014.8187.
- Stanley J, Peake JM, Buchheit M. Consecutive days of cold water immersion: effects on cycling performance and heart rate variability. Eur J Appl Physiol. 2013 Feb;113(2):371-84. doi: 10.1007/s00421-012-2445-2. Epub 2012 Jul 3.
- Buchheit M, Simpson BM, Garvican-Lewis LA, Hammond K, Kley M, Schmidt WF, Aughey RJ, Soria R, Sargent C, Roach GD, Claros JC, Wachsmuth N, Gore CJ, Bourdon PC. Wellness, fatigue and physical performance acclimatisation to a 2-week soccer camp at 3600 m (ISA3600). Br J Sports Med. 2013 Dec;47 Suppl 1(Suppl 1):i100-6. doi: 10.1136/bjsports-2013-092749.
- Jdidi H, Dugue B, de Bisschop C, Dupuy O, Douzi W. The effects of cold exposure (cold water immersion, whole- and partial- body cryostimulation) on cardiovascular and cardiac autonomic control responses in healthy individuals: A systematic review, meta-analysis and meta-regression. J Therm Biol. 2024 Apr;121:103857. doi: 10.1016/j.jtherbio.2024.103857. Epub 2024 Apr 18.
- Michalsen A, Ludtke R, Buhring M, Spahn G, Langhorst J, Dobos GJ. Thermal hydrotherapy improves quality of life and hemodynamic function in patients with chronic heart failure. Am Heart J. 2003 Oct;146(4):728-33. doi: 10.1016/S0002-8703(03)00314-4.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 janvier 2026
Achèvement primaire (Réel)
7 mars 2026
Achèvement de l'étude (Réel)
8 mars 2026
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
19 mai 2026
Première publication (Réel)
27 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
23 juin 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202502AS100005
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Description du régime IPD
The current research project has not yet been completed, and the data have not been publicly released.
After publication, sharing will be decided on a case-by-case basis.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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