- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07615478
Effect of Hot Spring Therapy on Central Fatigue Elimination During Altitude Training (HSCF-AHT)
22 maggio 2026 aggiornato da: 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).
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Stimato)
27
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ziyue Ou, PHD
- Numero di telefono: +8615626121623
- Email: p2521734@mpu.edu.mo
Luoghi di studio
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Macao
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Macao, Macao, Cina
- Reclutamento
- Macao Polytechnic University
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Contatto:
- Ziyue Ou, PHD
- Numero di telefono: +8615626121623
- Email: p2521734@mpu.edu.mo
-
Contatto:
- Ziyue Ou
- Numero di telefono: 15626121623
- Email: 105852022100090@stu.gzsport.edu.cn
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Sperimentale: 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.
|
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Voluntary Activation
Lasso di tempo: 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 (%).
|
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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Stroop Test Performance
Lasso di tempo: Baseline, Week 2,Week 4, Follow-up (Week 1-2 post-altitude)
|
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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
25 maggio 2026
Completamento primario (Stimato)
25 giugno 2026
Completamento dello studio (Stimato)
25 giugno 2026
Date di iscrizione allo studio
Primo inviato
19 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 maggio 2026
Primo Inserito (Effettivo)
29 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
29 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 202502AS100005-2
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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