Placebo Effect in Field-Based Physical Performance
31 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jakub Malik, PhD
- Numéro de téléphone: +48739975701
- E-mail: malik@awf.poznan.pl
Lieux d'étude
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Pologne
- Poznań University of Physical Education
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Contact:
- Jakub Malik, PhD
- Numéro de téléphone: +48739975701
- E-mail: malik@awf.poznan.pl
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Oui
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Comparateur factice: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Physical Performance Capacity (total distance in running, metres)
Délai: 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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Exercise Heart Rate (bpm)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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) (%)
Délai: 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)
Délai: 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) (%)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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 (%)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Jakub Malik, PhD, Poznan University of Physical Education, Department of Sports Psychology
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
31 mars 2028
Achèvement de l'étude (Estimé)
31 mars 2029
Dates d'inscription aux études
Première soumission
21 juillet 2026
Première soumission répondant aux critères de contrôle qualité
31 juillet 2026
Première publication (Réel)
3 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
3 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 152-1-26
- 2025/57/N/NZ4/04470 (Autre subvention/numéro de financement: National Science Centre)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .