Placebo Effect in Field-Based Physical Performance
31 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
120
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Jakub Malik, PhD
- Номер телефона: +48739975701
- Электронная почта: malik@awf.poznan.pl
Места учебы
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Польша
- Poznań University of Physical Education
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Контакт:
- Jakub Malik, PhD
- Номер телефона: +48739975701
- Электронная почта: malik@awf.poznan.pl
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Фальшивый компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical Performance Capacity (total distance in running, metres)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Exercise Heart Rate (bpm)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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) (%)
Временное ограничение: 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)
Временное ограничение: 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) (%)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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 (%)
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Jakub Malik, PhD, Poznan University of Physical Education, Department of Sports Psychology
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
31 марта 2028 г.
Завершение исследования (Оцененный)
31 марта 2029 г.
Даты регистрации исследования
Первый отправленный
21 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
31 июля 2026 г.
Первый опубликованный (Действительный)
3 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
3 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
31 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 152-1-26
- 2025/57/N/NZ4/04470 (Другой номер гранта/финансирования: National Science Centre)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана 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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .