- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07608913
Effect of Hot Spring Therapy on Cognitive Function Recovery During Altitude Training
19. Mai 2026 aktualisiert von: Ziyue Ou, Macao Polytechnic University
A Randomized Controlled Trial Investigating the Effects of Balneotherapy on Cognitive Performance, Cerebral Hemodynamics, and Exercise Capacity in Healthy Adults Undergoing Simulated Altitude Training
This randomized controlled trial aims to investigate the effects of hot spring bath therapy on cognitive function recovery, cerebral hemodynamics, and athletic performance in athletes undergoing altitude training.
Participants will be randomly assigned to either a hot spring intervention group, a hot water control group, or a blank control group.
The hot spring intervention group receives hot spring baths (38°C, 20 minutes) combined with altitude training; the hot water control group receives hot water baths (38°C, 20 minutes) combined with altitude training; and the blank control group receives standard recovery procedures combined with altitude training.
Primary outcome measures include cognitive performance assessments (Stroop test, psychomotor vigilance test) and cerebral hemodynamic indicators (functional near-infrared spectroscopy, transcranial Doppler ultrasound).
Secondary outcomes included exercise capacity (maximal oxygen uptake, triathlon performance, 500-meter test), blood lactate, and hematological parameters (white blood cells, neutrophils, platelets).
These findings may provide evidence for non-pharmacological interventions to enhance cognitive recovery and brain adaptation during altitude training.
Studienübersicht
Status
Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
27
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Ziyue Ou, PHD
- Telefonnummer: 15626121623
- E-Mail: 395356506@qq.com
Studienorte
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Macao, China
- Rekrutierung
- Macao Polytechnic University
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Kontakt:
- Ziyue Ou, PHD
- Telefonnummer: 15626121623
- E-Mail: 395356506@qq.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
Inclusion Criteria:
- Male or female aged 11-17 years- 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
- No color blindness or uncorrected visual impairment that would affect Stroop test performance
Exclusion Criteria:
- History of cardiovascular, respiratory, renal, or endocrine disorders
- Current use of medications affecting autonomic function or cognition (e.g., beta-blockers, anticholinergics, stimulants, sedatives)
- History of syncope, heat intolerance, or neurological disorders
- 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
- History of traumatic brain injury, stroke, or psychiatric disorders
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Aktiver 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.
Andere Namen:
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Aktiver 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.
Andere Namen:
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Experimental: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Psychomotor Vigilance Test (PVT)
Zeitfenster: 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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5-minute PVT measuring sustained attention and psychomotor vigilance.
Outcome variables: mean reciprocal response time (1/RT).
Administered via standardized software on a tablet/computer.
Unit: second.
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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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Stroop Test Performance
Zeitfenster: 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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Computerized Stroop Color-Word Test measuring executive function and cognitive inhibition.
Outcome variables: reaction time (ms).
Administered in a quiet, temperature-controlled room (22-24°C).
Unit: milliseconds (ms).
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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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Cerebral Oxygenation (fNIRS)
Zeitfenster: Baseline, Week 2, Week 5
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Changes in oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) in the prefrontal cortex during cognitive tasks, measured by functional near-infrared spectroscopy (fNIRS) with a multichannel system.
Outcome: relative changes in HbO and HbR concentrations.
Unit: micromolar (μM).
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Baseline, Week 2, Week 5
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Cerebral Blood Flow Velocity (TCD)
Zeitfenster: Baseline, Week 2, Week 4
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Mean blood flow velocity in the middle cerebral artery (MCA) and anterior cerebral artery (ACA) measured by transcranial Doppler ultrasound (TCD) with 2MHz probe.
Measurements taken in supine position after 10 minutes of rest.
Outcome: mean velocity (cm/s).
Unit: centimeters/second (cm/s).
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Baseline, Week 2, Week 4
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Maximal Oxygen Uptake (VO2max)
Zeitfenster: Baseline, Week 5
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Maximal oxygen uptake measured using a portable metabolic analyzer during a graded exercise test on a rowing ergometer.
Test protocol: incremental ramp test to exhaustion.
Unit: mL/kg/min.
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Baseline, Week 5
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1000-Meter Running Test
Zeitfenster: Baseline, Week 3, Week4
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1000-meter maximal effort running test on a standard 400m track or treadmill.
Total completion time recorded.
Unit: seconds (s).
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Baseline, Week 3, Week4
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Peripheral Oxygen Saturation (SpO2)
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
- 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.
- Ando S, Hatamoto Y, Sudo M, Kiyonaga A, Tanaka H, Higaki Y. The effects of exercise under hypoxia on cognitive function. PLoS One. 2013 May 10;8(5):e63630. doi: 10.1371/journal.pone.0063630. Print 2013.
- Ohori T, Nozawa T, Ihori H, Shida T, Sobajima M, Matsuki A, Yasumura S, Inoue H. Effect of repeated sauna treatment on exercise tolerance and endothelial function in patients with chronic heart failure. Am J Cardiol. 2012 Jan 1;109(1):100-4. doi: 10.1016/j.amjcard.2011.08.014. Epub 2011 Sep 23.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
25. Mai 2026
Primärer Abschluss (Geschätzt)
25. Juni 2026
Studienabschluss (Geschätzt)
25. Juni 2026
Studienanmeldedaten
Zuerst eingereicht
14. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
19. Mai 2026
Zuerst gepostet (Tatsächlich)
27. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
27. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
19. Mai 2026
Zuletzt verifiziert
1. Januar 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 202502AS100005-1
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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