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Placebo Effect in Field-Based Physical Performance

31. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen
        • Poznań University of Physical Education
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: 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.
Aktiv komparator: Placebo Group
Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol.
Annen: Placebo (Starch capsule)
Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol.
Sham-komparator: Control Group
Participants perform the same field-based exercise protocol without ingesting any capsule or active substance.
Annen: Sham (No Treatment)
Participants perform the same exercise protocols without any capsule or substance administration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical Performance Capacity (total distance in running, metres)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exercise Heart Rate (bpm)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Measured at the start of the protocol.
Body mass expressed in kilograms.
Measured at the start of the protocol.
Anthropometric Indices (m)
Tidsramme: 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)
Tidsramme: 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) (%)
Tidsramme: 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)
Tidsramme: 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) (%)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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 (%)
Tidsramme: 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)
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Poznan University of Physical Education

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. mars 2028

Studiet fullført (Antatt)

31. mars 2029

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

31. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 152-1-26
  • 2025/57/N/NZ4/04470 (Annet stipend/finansieringsnummer: National Science Centre)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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