Effect of Open-placebo Intervention on Cycling Performance

NCT ID: NCT03977246

Last Updated: 2019-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-09-30

Brief Summary

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This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.

Detailed Description

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This study investigated the effect of open-placebo on cycling time-trial (TT) performance. Twenty-eight trained female cyclists completed a 1-km cycling TT following a control session or an open-placebo intervention. The intervention consisted of an individual presentation, provided by a medic, in which the concept of open-placebo was explained to the participant, before she ingested two red and white capsules containing flour; 15 min later, they performed the TT. In the control session, the participant sat quietly for 20 min.

Conditions

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Exercise Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open-placebo

The open-placebo intervention session

Group Type EXPERIMENTAL

Open-placebo

Intervention Type BEHAVIORAL

Application of the open-placebo intervention

Control

The control session

Group Type PLACEBO_COMPARATOR

Control

Intervention Type BEHAVIORAL

Application of the control session

Interventions

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Open-placebo

Application of the open-placebo intervention

Intervention Type BEHAVIORAL

Control

Application of the control session

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Females aged between 18 and 45 years old;
* A minimum of one-year training experience in cycling.

Exclusion Criteria

* Smokers
* Chronic disease
* Prior or current use of steroids
* Use of creatine in the last 6 months
* Use of beta-alanine in the last 6 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Bruno Gualano

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno Gualano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status

School of Physical Education and Sport - USP

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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OpenPlaceboCycling

Identifier Type: -

Identifier Source: org_study_id

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