- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608913
Effect of Hot Spring Therapy on Cognitive Function Recovery During Altitude Training
19. maj 2026 opdateret af: 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.
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
-
-
-
Macao, Kina
- Rekruttering
- Macao Polytechnic University
-
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 11-17 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
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.
|
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:
|
|
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.
|
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:
|
|
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.
|
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:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Psychomotor Vigilance Test (PVT)
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.
|
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.
|
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.
|
|
Stroop Test Performance
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.
|
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).
|
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.
|
|
Cerebral Oxygenation (fNIRS)
Tidsramme: Baseline, Week 2, Week 5
|
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).
|
Baseline, Week 2, Week 5
|
|
Cerebral Blood Flow Velocity (TCD)
Tidsramme: Baseline, Week 2, Week 4
|
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).
|
Baseline, Week 2, Week 4
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximal Oxygen Uptake (VO2max)
Tidsramme: Baseline, Week 5
|
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.
|
Baseline, Week 5
|
|
1000-Meter Running Test
Tidsramme: Baseline, Week 3, Week4
|
1000-meter maximal effort running test on a standard 400m track or treadmill.
Total completion time recorded.
Unit: seconds (s).
|
Baseline, Week 3, Week4
|
|
Peripheral Oxygen Saturation (SpO2)
Tidsramme: one month.
|
Resting peripheral oxygen saturation measured via fingertip pulse oximeter after 10 minutes of seated rest.
Unit: percentage (%).
|
one month.
|
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
- 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.
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
- 202502AS100005-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Hypoxi
-
Leeds Beckett UniversityIkke rekrutterer endnuHumør | Kognitiv præstation | Arbejdshukommelse | Eksekutiv funktion (kognition) | Hypoxia inducerede kognitiv svækkelseDet Forenede Kongerige
-
The Jerzy Kukuczka Academy of Physical Education...Ministry of Science and Higher Education, PolandTilmelding efter invitationStrenght-træning med høj intensitet i Normoxia (H-N) | Lavintensiv strengenuddannelse i Normoxia (L-N) | Strenght-træning med høj intensitet i normobarisk hypoxia (H-H) | Lavintensiv strenght-træning i normobarisk hypoxia (L-H)Polen
Kliniske forsøg med Control Group:Natural Recovery
-
Washington University School of MedicineAktiv, ikke rekrutterende
-
Recovery Record ResearchStanford UniversityAfsluttetBulimia nervosa | Spiseforstyrrelser | Binge Eating DisorderForenede Stater
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...AfsluttetSvangerskabsforebyggelse | Udnyttelse af sundhedsvæsenet | PræventionsbrugForenede Stater
-
Prisma Health-UpstateMedical University of South Carolina; Clemson UniversityAfsluttet
-
Centre hospitalier de l'Université de Montréal...Centre de Recherche du Centre Hospitalier de l'Université de MontréalAfsluttet
-
Claire KellyUniversity College Dublin; Irish Research CouncilUkendt
-
Emory UniversityCenters for Disease Control and PreventionAfsluttetStofbrugsforstyrrelserForenede Stater
-
Life Recovery SystemsIkke rekrutterer endnuST-elevation myokardieinfarktForenede Stater
-
Center for Social Innovation, MassachusettsYale UniversityAfsluttetPsykiske lidelser | AdfærdsforstyrrelserForenede Stater
-
VA Office of Research and DevelopmentAfsluttet