Placebo Effect in Field-Based Physical Performance
31 de julio de 2026 actualizado por: Poznan University of Physical Education
Psychophysiological Mechanisms of the Placebo Effect on Physical Performance in Field Settings
This study aims to investigate the placebo (PLA) effect on physical performance across different sports disciplines in real-world, field-based settings.
The study investigates how participant expectations and beliefs regarding caffeine (CAF) intake influence physical performance and psychomotor function outside the controlled laboratory environment.
Healthy, physically active adults (n = 120) from diverse sports backgrounds will be randomly assigned to receive caffeine, placebo, or no intervention.
Participants will perform discipline-specific field exercise tests (e.g., running-based protocols or repeated sprint protocols) while physiological responses are monitored using wearable technology.
Physical performance outcomes and psychomotor responses will be analyzed to evaluate the real-world impact of the placebo effect and to distinguish the pharmacological effects of caffeine from those driven by psychological expectations across different athletic settings.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This study employs a cross-sectional design conducted in diverse field settings to investigate the placebo (PLA) effect across different sports disciplines.
Participants (n = 120, aged 20-35 years) representing different training profiles (endurance and mixed) will be randomly assigned to one of three parallel groups: Caffeine, Placebo, or Control.
Each participant will complete a single experimental session lasting approximately 35 minutes, consisting of: (1) baseline psychomotor assessment using the Simple Reaction Time test, (2) a discipline-specific exercise protocol (e.g., the Cooper test performed on an athletics track or a Repeated Sprint Ability protocol), and (3) post-exercise recovery monitoring.
Physiological parameters, including heart rate (HR), heart rate variability (HRV), and respiratory rate (RR), together with postural stability, will be continuously monitored using wearable technology.
The study will evaluate how psychological expectations influence physical performance, psychomotor function, and physiological responses during sport-specific exercise, providing evidence for the role of the placebo effect under real-world athletic conditions.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
120
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: Jakub Malik, PhD
- Número de teléfono: +48739975701
- Correo electrónico: malik@awf.poznan.pl
Ubicaciones de estudio
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polonia
- Poznań University of Physical Education
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Contacto:
- Jakub Malik, PhD
- Número de teléfono: +48739975701
- Correo electrónico: malik@awf.poznan.pl
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age between 20 and 35 years,
- Healthy adults,
- Regular physical activity,
- Normal or corrected-to-normal vision,
- Habitual caffeine consumption.
Exclusion Criteria:
- History of neurological, psychiatric, cardiovascular, or metabolic disorders,
- Current use of medication or supplements affecting the central nervous system,
- Musculoskeletal injuries that would impair physical performance,
- No habitual caffeine consumption or severe negative side effects of caffeine,
- Diagnosed sleep disorders or chronic fatigue,
- Diagnosed major depressive disorder or other severe psychiatric conditions,
- Presence of any menstrual disorders,
- Inability to attend all experimental study visits.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Caffeine Group
Participants ingest a single dose of caffeine (6mg/kg body mass) prior to a field-based exercise protocol (e.g., Cooper test or Repeated Sprint Ability).
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Anhydrous caffeine administered in an encapsulated form at a dosage of 6mg per kilogram of body mass, 30-60 minutes before the exercise protocol.
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Comparador activo: Placebo Group
Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol.
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Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol.
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Comparador falso: Control Group
Participants perform the same field-based exercise protocol without ingesting any capsule or active substance.
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Participants perform the same exercise protocols without any capsule or substance administration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical Performance Capacity (total distance in running, metres)
Periodo de tiempo: Measured during the exercise protocol immediately following administration of the study intervention.
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Total physical work capacity measured as the total running distance (metres) completed during the standardized exercise protocol.
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Measured during the exercise protocol immediately following administration of the study intervention.
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Physical Performance Capacity (total work in Joules for cycling)
Periodo de tiempo: Measured during the exercise protocol immediately following administration of the study intervention.
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Total physical work capacity measured as the total mechanical work (Joules) completed during the standardized cycling exercise protocol.
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Measured during the exercise protocol immediately following administration of the study intervention.
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Physical Performance Capacity (exercise duration until exhaustion, minutes)
Periodo de tiempo: Measured during the exercise protocol immediately following administration of the study intervention.
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Total physical work capacity measured as exercise duration until volitional exhaustion during the standardized exercise protocol.
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Measured during the exercise protocol immediately following administration of the study intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Exercise Heart Rate (bpm)
Periodo de tiempo: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Heart rate (beats per minute) recorded continuously throughout the standardized exercise protocol.
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Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Cognitive Heart Rate (bpm)
Periodo de tiempo: Measured during cognitive testing immediately before and immediately after the exercise protocol.
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Heart rate recorded during standardized cognitive performance tasks.
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Measured during cognitive testing immediately before and immediately after the exercise protocol.
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Post-Exercise Heart Rate Recovery (bpm)
Periodo de tiempo: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
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Heart rate recorded during the post-exercise recovery period.
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Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
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Cognitive Reaction Time (ms)
Periodo de tiempo: Measured immediately before and immediately after the exercise protocol.
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Reaction time measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
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Measured immediately before and immediately after the exercise protocol.
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Rating of Perceived Exertion (Borg Scale, points)
Periodo de tiempo: Measured immediately after completion of the exercise protocol.
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Perceived exertion assessed using the Borg Rating of Perceived Exertion Scale (6-20).
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Measured immediately after completion of the exercise protocol.
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Biomechanical Kinematic Profile (cm)
Periodo de tiempo: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Continuous recording of kinematic parameters derived from wearable sensors, including step length and vertical oscillation.
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Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Biomechanical Kinematic Profile (ms)
Periodo de tiempo: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Continuous recording of stance time derived from wearable sensor data.
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Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Biomechanical Kinematic Profile (steps/min)
Periodo de tiempo: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Continuous recording of cadence derived from wearable sensor data.
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Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Anthropometric Indices (kg)
Periodo de tiempo: Measured at the start of the protocol.
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Body mass expressed in kilograms.
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Measured at the start of the protocol.
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Anthropometric Indices (m)
Periodo de tiempo: Measured at the start of the protocol.
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Height expressed in metres.
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Measured at the start of the protocol.
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Body composition (fat-free mass, fat mass) (kg)
Periodo de tiempo: Measured at the start of the protocol.
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Assessment of body composition (fat-free mass, fat mass) (kg) will be performed at the start of the protocol.
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Measured at the start of the protocol.
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Body composition (fat-free mass, fat mass) (%)
Periodo de tiempo: Measured at the start of the protocol.
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Assessment of body composition (fat-free mass, fat mass) (%) will be performed at the start of the protocol.
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Measured at the start of the protocol.
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Body composition (total body water) (L)
Periodo de tiempo: Measured at the start of the protocol.
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Assessment of body composition (total body water) (L) will be performed at baseline at the start of the protocol.
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Measured at the start of the protocol.
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Body composition (total body water) (%)
Periodo de tiempo: Measured at the start of the protocol.
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Assessment of body composition (total body water) (%) will be performed at baseline at the start of the protocol.
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Measured at the start of the protocol.
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Exercise Heart Rate Variability (ms)
Periodo de tiempo: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Heart rate variability recorded continuously throughout the standardized exercise protocol to assess autonomic regulation.
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Continuously monitored during the exercise protocol immediately following administration of the study intervention.
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Cognitive Heart Rate Variability (ms)
Periodo de tiempo: Measured during cognitive testing immediately before and immediately after the exercise protocol.
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Heart rate variability recorded during standardized cognitive performance tasks.
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Measured during cognitive testing immediately before and immediately after the exercise protocol.
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Post-Exercise Heart Rate Variability Recovery (ms)
Periodo de tiempo: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
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Heart rate variability recorded during the post-exercise recovery period.
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Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
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Cognitive Accuracy (%)
Periodo de tiempo: Measured immediately before and immediately after the exercise protocol.
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Accuracy measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
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Measured immediately before and immediately after the exercise protocol.
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Performance Expectancy (points)
Periodo de tiempo: Measured immediately after completion of the exercise protocol.
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Measured immediately before the exercise protocol following administration of the study intervention.
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Measured immediately after completion of the exercise protocol.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jakub Malik, PhD, Poznan University of Physical Education, Department of Sports Psychology
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)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de marzo de 2028
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 152-1-26
- 2025/57/N/NZ4/04470 (Otro número de subvención/financiamiento: National Science Centre)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The decision regarding the sharing of individual participant data has not yet been finalized.
We are currently evaluating the feasibility, ethical considerations, and data privacy requirements for potential data sharing.
A formal plan will be developed and implemented in accordance with institutional policies and regulatory standards upon the completion of the study.
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. .