- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07615478
Effect of Hot Spring Therapy on Central Fatigue Elimination During Altitude Training (HSCF-AHT)
22. května 2026 aktualizováno: Ziyue Ou, Macao Polytechnic University
A Randomized Controlled Trial Investigating the Effects of Hot Spring Therapy Balneotherapy on Central Activation, Cognitive Function, and Exercise Performance in Adolescent Rowers During Altitude Training
This randomized controlled trial investigates the effects of hot spring balneotherapy on central fatigue elimination in adolescent rowers undergoing altitude training at approximately 1600 meters (Tengchong, Yunnan).
Thirty adolescent athletes (aged 12-16 years) will be stratified by sex and randomly allocated to three groups: Group A (natural recovery, no immersion), Group B (38°C pure water immersion), and Group C (38°C sodium bicarbonate hot spring immersion).
Interventions will be administered 3 times per week for 4 weeks.
The primary outcomes are central fatigue indices including voluntary activation (VA) and central activation ratio (CAR).
Secondary outcomes encompass cognitive function (Stroop test, Psychomotor Vigilance Test), cerebral hemodynamics (functional near-infrared spectroscopy, transcranial Doppler ultrasound), exercise performance (maximal oxygen uptake, 1000m test, 500m test), blood lactate, and hematological parameters (white blood cells, neutrophils, platelets).
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
Altitude training induces central fatigue characterized by decreased descending neural drive from the brain to skeletal muscle, reduced voluntary activation, and impaired cognitive function.
This study employs a stratified randomized block design to evaluate whether post-exercise hot spring immersion can accelerate central fatigue recovery compared to pure warm water immersion and natural recovery.
All participants will undergo standardized rowing training at approximately 1600 meters altitude.
Group C will receive immersion in natural hot spring water at 38°C for 20 minutes.
Group B will receive immersion in pure water at the same temperature and duration as a thermal control.
Group A will undergo standard training recovery without immersion.
The study incorporates partial blinding: Groups B and C are single-blinded to participants (identical appearance and protocol); Group A serves as an open-label control.
Assessments will be conducted at baseline (pre-altitude), mid-intervention (Week 2), end-intervention (Week 4), and follow-up (1-2 weeks post-altitude).
Typ studie
Intervenční
Zápis (Odhadovaný)
27
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Ziyue Ou, PHD
- Telefonní číslo: +8615626121623
- E-mail: p2521734@mpu.edu.mo
Studijní místa
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Macao
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Macao, Macao, Čína
- Nábor
- Macao Polytechnic University
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Kontakt:
- Ziyue Ou, PHD
- Telefonní číslo: +8615626121623
- E-mail: p2521734@mpu.edu.mo
-
Kontakt:
- Ziyue Ou
- Telefonní číslo: 15626121623
- E-mail: 105852022100090@stu.gzsport.edu.cn
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-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Ano
Popis
Inclusion Criteria:
- Male or female aged 12-16 years- Healthy with no serious chronic diseases or skin conditions
- At least 1 year of systematic rowing training experience
- Currently undergoing centralized altitude training at approximately 1600 meters- No history of systematic hot spring or spa immersion within the past month
- No allergy history to sodium bicarbonate or hot spring minerals- Ability to provide written informed assent (participant) and written informed consent (parent/guardian)- No acute infection, fracture, or surgery within the past month
- Not currently taking non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressants, or medications affecting autonomic or cognitive function
Exclusion Criteria:
- History of cardiovascular, respiratory, renal, endocrine, or neurological disorders- Uncontrolled hypertension or hypotension
- History of syncope, heat intolerance, or severe dizziness during hot water immersion- Open wounds, severe eczema, or other skin conditions contraindicating water immersion
- Current use of beta-blockers, anticholinergics, stimulants, sedatives, or other medications affecting central nervous system function
- Color blindness or uncorrected visual impairment affecting Stroop test performance- Pregnancy (for female participants)- Alcohol consumption or smoking
- Shift work or trans-meridian travel within 2 weeks prior to baseline assessment
- Any condition deemed by the investigator as unsafe for participation
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Natural Recovery Group
Participants in Group A will undergo standardized rowing training at approximately 1600 meters altitude for 4 weeks.
After each training session, participants will receive standard training recovery procedures without any water immersion intervention.
Recovery includes passive rest, self-directed light stretching, and ad libitum hydration in a thermoneutral environment (room temperature 24°C) for 20 minutes.
No thermal or hydrotherapy intervention will be provided.
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Standard post-exercise recovery without water immersion.
Participants rest passively in a thermoneutral environment (24°C, 50-60% humidity) for 20 minutes with ad libitum water and optional self-directed stretching.
No heat, cold, or hydrotherapy interventions are applied.
Ostatní jména:
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Aktivní komparátor: Hot water immersion group
Subjects in Group B will undergo the same standardized rowing training at an altitude of approximately 1600 meters for 4 weeks.
After each training session, subjects will receive whole-body immersion (below the neck, with the head above water) in daily tap water at 38°C ± 0.5°C for 20 minutes.
The water temperature is monitored by a precision thermometer with an error of ≤ ±0.5°C.
The immersion is conducted in a standardized indoor facility, and the time is 16:00 on Tuesday, Thursday, and Saturday.
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After exercise, full-body immersion in daily tap water.
Temperature: 38°C ± 0.5°C.
Duration: 20 minutes per session, 3 times per week (Tuesday, Thursday, Saturday at 16:00), for 4 consecutive weeks (total of 12 sessions).
Protocol: Full-body immersion below the neck for 20 minutes, followed by a 10-minute rest before leaving the facility.
Ostatní jména:
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Experimentální: Hot Spring Immersion Group
Participants in Group C will undergo the same standardized rowing training at approximately 1600 meters altitude for 4 weeks.
After each training session, participants will receive full-body immersion (below neck, head above water) in natural hot spring water at 38°C ± 0.5°C for 20 minutes.
The spring water has a pH of approximately 7.4, Na+ content of 1210 mg/L, and HCO3- content of approximately 3300 mg/L.
Immersion will be performed in a standardized indoor facility on Tuesday, Thursday, and Saturday at 16:00, using the same protocol as Group B to maintain blinding.
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After exercise, full-body immersion in natural hot spring water (pH approx.
7.4, Na+ 1210 mg/L, HCO3- approx.
3300 mg/L, total dissolved solids >1000 mg/L).
Temperature: 38°C ± 0.5°C.
Duration: 20 minutes per session, 3 times per week (Tuesday, Thursday, Saturday at 16:00), for 4 consecutive weeks (12 sessions total).
Protocol: Full-body immersion below the neck for 20 minutes, followed by a 10-minute rest before leaving the facility.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Voluntary Activation
Časové okno: Baseline (Week 0), Week 2, Week 3, Week 4 (post-intervention), Follow-up (Week 1-2 post-altitude)
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Voluntary activation assessed by the interpolated twitch technique (ITT) during maximal voluntary contraction (MVC) of the quadriceps femoris using percutaneous electrical stimulation.
A single stimulus is superimposed on MVC; VA is calculated as: VA = (1 - superimposed twitch force / potentiated resting doublet force) × 100%.
Higher VA indicates greater central neural drive.
Unit: percentage (%).
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Baseline (Week 0), Week 2, Week 3, Week 4 (post-intervention), Follow-up (Week 1-2 post-altitude)
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Central Activation Ratio
Časové okno: Baseline (Week 0), Week 2, Week 3, Week 4, Follow-up (Week 5-6 post-altitude)
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Central activation ratio measured as the ratio of maximal voluntary contraction force to the force evoked by supramaximal electrical stimulation of the femoral nerve during quadriceps contraction.
CAR = MVC force / (MVC force + superimposed twitch force).
Values closer to 1.0 indicate less central fatigue.
Unit: ratio (0-1, no units).
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Baseline (Week 0), Week 2, Week 3, Week 4, Follow-up (Week 5-6 post-altitude)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Stroop Test Performance
Časové okno: Baseline, Week 2,Week 4, Follow-up (Week 1-2 post-altitude)
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Computerized Stroop Color-Word Test measuring executive function and cognitive inhibition.
Outcome variables: reaction time (ms) for congruent and incongruent trials, with interference effect calculated as incongruent minus congruent reaction time.
Administered in a quiet, temperature-controlled room (22-24°C).
Unit: milliseconds (ms).
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Baseline, Week 2,Week 4, Follow-up (Week 1-2 post-altitude)
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Cerebral Oxygenation
Časové okno: Baseline, Week 2, fellow up
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Changes in oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) in the prefrontal cortex during rest and cognitive tasks, measured by functional near-infrared spectroscopy (fNIRS) with a multichannel system.
Outcome: relative concentration changes (ΔμM) in HbO2 and Hb from baseline.
Unit: micromolar (μM).
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Baseline, Week 2, fellow up
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Psychomotor Vigilance Test
Časové okno: Baseline, Week 2, Week 3, Week 4, Follow-up (Week 1-2 post-altitude)
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5-minute Psychomotor Vigilance Test measuring sustained attention and psychomotor vigilance.
Outcome variables: mean response time, and number of lapses (reaction time >500 ms).
Administered via standardized software on a tablet/computer in a quiet environment.
Unit: milliseconds (ms).
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Baseline, Week 2, Week 3, Week 4, Follow-up (Week 1-2 post-altitude)
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Maximal Oxygen Uptake (VO2max)
Časové okno: Baseline (Week 0), Follow-up (Week 5-6 post-altitude)
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Maximal oxygen uptake measured during a graded exercise test on a rowing ergometer using a portable metabolic cart.
Protocol: incremental ramp test (starting at 100W, increasing 20W every 2 minutes) until volitional exhaustion.
Unit: mL/kg/min.
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Baseline (Week 0), Follow-up (Week 5-6 post-altitude)
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White Blood Cell Count (WBC)
Časové okno: Baseline, Week 2, Follow up (Week 5-6 post-altitude)
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Total white blood cell count measured from fasting venous blood sample using automated hematology analyzer.
Unit: 10^9 cells per liter (10^9/L).
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Baseline, Week 2, Follow up (Week 5-6 post-altitude)
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Neutrophil Count (NEUT)
Časové okno: Baseline, Week 2, Follow-up (Week 5-6 post-altitude)
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Absolute neutrophil count measured from fasting venous blood sample using automated hematology analyzer.
Unit: 10^9/L.
Baseline, Week 4 11 Platelet Count (PLT) Platelet count measured from fasting venous blood sample using automated hematology analyzer.
Unit: 10^9/L.
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Baseline, Week 2, Follow-up (Week 5-6 post-altitude)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Roerink ME, van der Schaaf ME, Dinarello CA, Knoop H, van der Meer JW. Interleukin-1 as a mediator of fatigue in disease: a narrative review. J Neuroinflammation. 2017 Jan 21;14(1):16. doi: 10.1186/s12974-017-0796-7.
- Goodall S, Gonzalez-Alonso J, Ali L, Ross EZ, Romer LM. Supraspinal fatigue after normoxic and hypoxic exercise in humans. J Physiol. 2012 Jun 1;590(11):2767-82. doi: 10.1113/jphysiol.2012.228890. Epub 2012 Apr 2.
- Ando S, Tsukamoto H, Stacey BS, Washio T, Owens TS, Calverley TA, Fall L, Marley CJ, Iannetelli A, Hashimoto T, Ogoh S, Bailey DM. Acute hypoxia impairs posterior cerebral bioenergetics and memory in man. Exp Physiol. 2023 Dec;108(12):1516-1530. doi: 10.1113/EP091245. Epub 2023 Oct 29.
- Koral J, Oranchuk DJ, Wrightson JG, Twomey R, Millet GY. Mechanisms of neuromuscular fatigue and recovery in unilateral versus bilateral maximal voluntary contractions. J Appl Physiol (1985). 2020 Apr 1;128(4):785-794. doi: 10.1152/japplphysiol.00651.2019. Epub 2020 Mar 12.
- Amann M, Sidhu SK, McNeil CJ, Gandevia SC. Critical considerations of the contribution of the corticomotoneuronal pathway to central fatigue. J Physiol. 2022 Dec;600(24):5203-5214. doi: 10.1113/JP282564. Epub 2022 Nov 23.
- Tamaoki S, Matsumoto S, Sasa N, Hoei T, Tojo R, Nakamura T, Aoyagi Y. Effects of sodium bicarbonate bath on the quality of sleep: An assessor-blinded, randomized, controlled, pilot clinical trial. Complement Ther Clin Pract. 2023 Feb;50:101714. doi: 10.1016/j.ctcp.2022.101714. Epub 2022 Dec 14.
- Grgic J, Pedisic Z, Saunders B, Artioli GG, Schoenfeld BJ, McKenna MJ, Bishop DJ, Kreider RB, Stout JR, Kalman DS, Arent SM, VanDusseldorp TA, Lopez HL, Ziegenfuss TN, Burke LM, Antonio J, Campbell BI. International Society of Sports Nutrition position stand: sodium bicarbonate and exercise performance. J Int Soc Sports Nutr. 2021 Sep 9;18(1):61. doi: 10.1186/s12970-021-00458-w.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
25. května 2026
Primární dokončení (Odhadovaný)
25. června 2026
Dokončení studie (Odhadovaný)
25. června 2026
Termíny zápisu do studia
První předloženo
19. května 2026
První předloženo, které splnilo kritéria kontroly kvality
22. května 2026
První zveřejněno (Aktuální)
29. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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Popis plánu IPD
The project is still ongoing, and there are no current plans to contribute the data.
Whether to share it will be considered after the data is officially published.
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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