- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608887
Effect of Hot Spring Therapy on Autonomic Nervous System and Exercise Performance During Altitude Training
19. maj 2026 opdateret af: Ziyue Ou, Macao Polytechnic University
A Randomized Controlled Trial Investigating the Effects of Balneotherapy on Cardiac Autonomic Modulation and Athletic Performance in Healthy Adults Undergoing Simulated Altitude Training Undergoing Simulated 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
27
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ziyue Ou, PHD
- Telefonnummer: 15626121623
- E-mail: 395356506@qq.com
Studiesteder
-
-
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Macao, Kina
- Rekruttering
- Macao Polytechnic University
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Kontakt:
- Ziyue Ou, PHD
- Telefonnummer: 15626121623
- E-mail: 395356506@qq.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ja
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: 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.
Andre navne:
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Aktiv komparator: 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 includes whole-body immersion up to the neck 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 includes whole-body immersion up to the neck for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
Andre navne:
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Eksperimentel: 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 includes whole-body immersion to the neck 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 includes whole-body immersion to the neck for 20 minutes, followed by a 10-minute rest before leaving the facility.
Three times per week.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Heart Rate Variability (HRV) - RMSSD
Tidsramme: 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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1000-meter ergometer test.
Tidsramme: Baseline measurements were taken before the official start of the experiment and during the 3rd and 4th weeks after ascending to the plateau.
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Perform a 1000-meter all-out test on a rowing ergometer.
Protocol: sprint at maximum effort to measure the shortest time.
Record time.
Units: seconds.
Baseline, Week 3, Week 4.
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Baseline measurements were taken before the official start of the experiment and during the 3rd and 4th weeks after ascending to the plateau.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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HRV - SDNN
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
25. maj 2026
Primær færdiggørelse (Anslået)
25. juni 2026
Studieafslutning (Anslået)
25. juni 2026
Datoer for studieregistrering
Først indsendt
14. maj 2026
Først indsendt, der opfyldte QC-kriterier
19. maj 2026
Først opslået (Faktiske)
27. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202502AS100005
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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.
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