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Placebo Effect in Field-Based Physical Performance

2026年7月31日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • ポーランド
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、ポーランド
        • Poznań University of Physical Education
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
薬：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.
アクティブコンパレータ：Placebo Group
Participants ingest a single dose of placebo (corn starch) in an identical capsule prior to a field-based exercise protocol.
他の：Placebo (Starch capsule)
Corn starch administered in an identical encapsulated form as the active caffeine, 30-60 minutes before the exercise protocol.
偽コンパレータ：Control Group
Participants perform the same field-based exercise protocol without ingesting any capsule or active substance.
他の：Sham (No Treatment)
Participants perform the same exercise protocols without any capsule or substance administration.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Physical Performance Capacity (total distance in running, metres)
時間枠：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)
時間枠：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)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Exercise Heart Rate (bpm)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：Measured at the start of the protocol.
Body mass expressed in kilograms.
Measured at the start of the protocol.
Anthropometric Indices (m)
時間枠：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)
時間枠：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) (%)
時間枠：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)
時間枠：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) (%)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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 (%)
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Poznan University of Physical Education

捜査官

  • 主任研究者：Jakub Malik, PhD、Poznan University of Physical Education, Department of Sports Psychology

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年3月31日

研究の完了 (推定)

2029年3月31日

試験登録日

最初に提出

2026年7月21日

QC基準を満たした最初の提出物

2026年7月31日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月3日

QC基準を満たした最後の更新が送信されました

2026年7月31日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 152-1-26
  • 2025/57/N/NZ4/04470 (その他の助成金/資金番号：National Science Centre)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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.

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この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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