- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07608913
Effect of Hot Spring Therapy on Cognitive Function Recovery During Altitude Training
19 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
27
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ziyue Ou, PHD
- Número de teléfono: 15626121623
- Correo electrónico: 395356506@qq.com
Ubicaciones de estudio
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Macao, Porcelana
- Reclutamiento
- Macao Polytechnic University
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Contacto:
- Ziyue Ou, PHD
- Número de teléfono: 15626121623
- Correo electrónico: 395356506@qq.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: 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.
Otros nombres:
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Comparador activo: 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.
Otros nombres:
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Psychomotor Vigilance Test (PVT)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maximal Oxygen Uptake (VO2max)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
25 de mayo de 2026
Finalización primaria (Estimado)
25 de junio de 2026
Finalización del estudio (Estimado)
25 de junio de 2026
Fechas de registro del estudio
Enviado por primera vez
14 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202502AS100005-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Control Group:Natural Recovery
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National Cheng-Kung University HospitalTerminado
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Recovery Record ResearchStanford UniversityTerminadoBulimia nerviosa | Trastornos de la alimentación | Trastorno por atracónEstados Unidos
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University of Colorado, DenverTerminadoTrastorno por consumo de alcohol (AUD)Estados Unidos
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Hangzhou Normal UniversityTerminadoTrastorno de la conciencia | Estado de mínima concienciaPorcelana
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Duke UniversityTerminado
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BDH-Klinik Hessisch OldendorfReclutamientoCarrera | Lesión cerebral traumática | Trastorno neurológico | Trastorno de la conciencia | Encefalopatía hipóxico-isquémicaAlemania
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Hangzhou Normal UniversityTerminadoEstado de mínima conciencia | Estado vegetativo
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Queen's UniversityTerminadoEficacia del Cuaderno de Recuperación como Herramienta Psicoeducativa para Facilitar la RecuperaciónDesordenes mentalesCanadá
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Michigan State UniversityTerminadoEl foco del estudio es determinar la eficacia de CompexEstados Unidos
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Kocaeli Derince Education and Research HospitalKocaeli UniversityDesconocidoRecuperación mejorada después de la cirugía | Cirugía a corazón abiertoPavo