- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07615478
Effect of Hot Spring Therapy on Central Fatigue Elimination During Altitude Training (HSCF-AHT)
22 maj 2026 uppdaterad av: 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).
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Interventionell
Inskrivning (Beräknad)
27
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Ziyue Ou, PHD
- Telefonnummer: +8615626121623
- E-post: p2521734@mpu.edu.mo
Studieorter
-
-
Macao
-
Macao, Macao, Kina
- Rekrytering
- Macao Polytechnic University
-
Kontakt:
- Ziyue Ou, PHD
- Telefonnummer: +8615626121623
- E-post: p2521734@mpu.edu.mo
-
Kontakt:
- Ziyue Ou
- Telefonnummer: 15626121623
- E-post: 105852022100090@stu.gzsport.edu.cn
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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.
|
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.
Andra namn:
|
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Aktiv komparator: 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.
|
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.
Andra namn:
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Voluntary Activation
Tidsram: Baseline (Week 0), Week 2, Week 3, Week 4 (post-intervention), Follow-up (Week 1-2 post-altitude)
|
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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stroop Test Performance
Tidsram: 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
Tidsram: 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).
|
Baseline, Week 2, fellow up
|
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Psychomotor Vigilance Test
Tidsram: Baseline, Week 2, Week 3, Week 4, Follow-up (Week 1-2 post-altitude)
|
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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
25 maj 2026
Primärt slutförande (Beräknad)
25 juni 2026
Avslutad studie (Beräknad)
25 juni 2026
Studieregistreringsdatum
Först inskickad
19 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 202502AS100005-2
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Whether to share it will be considered after the data is officially published.
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