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Placebo Effect in Field-Based Physical Performance

31 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Polska
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polska
        • Poznań University of Physical Education
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Lek: Caffeine (6mg/kg)
Anhydrous caffeine administered in an encapsulated form at a dosage of 6mg per kilogram of body mass, 30-60 minutes before the exercise protocol.
Aktywny komparator: Placebo Group
Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol.
Inny: Placebo (Starch capsule)
Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol.
Pozorny komparator: Control Group
Participants perform the same field-based exercise protocol without ingesting any capsule or active substance.
Inny: Sham (No Treatment)
Participants perform the same exercise protocols without any capsule or substance administration.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Physical Performance Capacity (total distance in running, metres)
Ramy czasowe: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as the total running distance (metres) completed during the standardized exercise protocol.
Measured during the exercise protocol immediately following administration of the study intervention.
Physical Performance Capacity (total work in Joules for cycling)
Ramy czasowe: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as the total mechanical work (Joules) completed during the standardized cycling exercise protocol.
Measured during the exercise protocol immediately following administration of the study intervention.
Physical Performance Capacity (exercise duration until exhaustion, minutes)
Ramy czasowe: Measured during the exercise protocol immediately following administration of the study intervention.
Total physical work capacity measured as exercise duration until volitional exhaustion during the standardized exercise protocol.
Measured during the exercise protocol immediately following administration of the study intervention.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Exercise Heart Rate (bpm)
Ramy czasowe: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Heart rate (beats per minute) recorded continuously throughout the standardized exercise protocol.
Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate (bpm)
Ramy czasowe: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Heart rate recorded during standardized cognitive performance tasks.
Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Recovery (bpm)
Ramy czasowe: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Heart rate recorded during the post-exercise recovery period.
Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Reaction Time (ms)
Ramy czasowe: Measured immediately before and immediately after the exercise protocol.
Reaction time measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
Measured immediately before and immediately after the exercise protocol.
Rating of Perceived Exertion (Borg Scale, points)
Ramy czasowe: Measured immediately after completion of the exercise protocol.
Perceived exertion assessed using the Borg Rating of Perceived Exertion Scale (6-20).
Measured immediately after completion of the exercise protocol.
Biomechanical Kinematic Profile (cm)
Ramy czasowe: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Continuous recording of kinematic parameters derived from wearable sensors, including step length and vertical oscillation.
Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (ms)
Ramy czasowe: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Continuous recording of stance time derived from wearable sensor data.
Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Biomechanical Kinematic Profile (steps/min)
Ramy czasowe: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Continuous recording of cadence derived from wearable sensor data.
Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Anthropometric Indices (kg)
Ramy czasowe: Measured at the start of the protocol.
Body mass expressed in kilograms.
Measured at the start of the protocol.
Anthropometric Indices (m)
Ramy czasowe: Measured at the start of the protocol.
Height expressed in metres.
Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (kg)
Ramy czasowe: Measured at the start of the protocol.
Assessment of body composition (fat-free mass, fat mass) (kg) will be performed at the start of the protocol.
Measured at the start of the protocol.
Body composition (fat-free mass, fat mass) (%)
Ramy czasowe: Measured at the start of the protocol.
Assessment of body composition (fat-free mass, fat mass) (%) will be performed at the start of the protocol.
Measured at the start of the protocol.
Body composition (total body water) (L)
Ramy czasowe: Measured at the start of the protocol.
Assessment of body composition (total body water) (L) will be performed at baseline at the start of the protocol.
Measured at the start of the protocol.
Body composition (total body water) (%)
Ramy czasowe: Measured at the start of the protocol.
Assessment of body composition (total body water) (%) will be performed at baseline at the start of the protocol.
Measured at the start of the protocol.
Exercise Heart Rate Variability (ms)
Ramy czasowe: Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Heart rate variability recorded continuously throughout the standardized exercise protocol to assess autonomic regulation.
Continuously monitored during the exercise protocol immediately following administration of the study intervention.
Cognitive Heart Rate Variability (ms)
Ramy czasowe: Measured during cognitive testing immediately before and immediately after the exercise protocol.
Heart rate variability recorded during standardized cognitive performance tasks.
Measured during cognitive testing immediately before and immediately after the exercise protocol.
Post-Exercise Heart Rate Variability Recovery (ms)
Ramy czasowe: Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Heart rate variability recorded during the post-exercise recovery period.
Continuously monitored during the first 5 minutes immediately following completion of the exercise protocol.
Cognitive Accuracy (%)
Ramy czasowe: Measured immediately before and immediately after the exercise protocol.
Accuracy measured during standardized cognitive tasks (e.g., Psychomotor Vigilance Test, Stroop Test, Flanker Test).
Measured immediately before and immediately after the exercise protocol.
Performance Expectancy (points)
Ramy czasowe: Measured immediately after completion of the exercise protocol.
Measured immediately before the exercise protocol following administration of the study intervention.
Measured immediately after completion of the exercise protocol.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Poznan University of Physical Education

Śledczy

  • Główny śledczy: Jakub Malik, PhD, Poznan University of Physical Education, Department of Sports Psychology

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

31 marca 2028

Ukończenie studiów (Szacowany)

31 marca 2029

Daty rejestracji na studia

Pierwszy przesłany

21 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 lipca 2026

Pierwszy wysłany (Rzeczywisty)

3 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 152-1-26
  • 2025/57/N/NZ4/04470 (Inny numer grantu/finansowania: National Science Centre)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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