Exercise PerformanceNCT03977246
Effect of Open-placebo Intervention on Cycling Performance
A study of Exercise Performance, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 May 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged between 18 and 45 years old;
- A minimum of one-year training experience in cycling.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Sao Paulo
São Paulo, 05508-30
School of Physical Education and Sport - USP
São Paulo, 05508030
About this study
Official title: The Effect of an Open-placebo Intervention on Cycling Time-trial Performance
This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.
Read the detailed description
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
- Exercise Performance
- Being tested
- Open-placebo, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-placeboBehavioural
Application of the open-placebo intervention
ControlBehavioural
Application of the control session
| Study group | Role | What they receive |
|---|---|---|
| Open-placebo | Experimental | The open-placebo intervention session Receives: Behavioral: Open-placebo |
| Control | Placebo comparator | The control session Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance
Change in 1 km cycling time-trial performance
Measured: 20-min following open-placebo intervention
Secondary outcomes (1)
Blood lactate
Change in blood lactate concentration
Measured: Immediately post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 May 2018
- Primary completion30 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise PerformanceStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977246
- Sponsor's protocol ID
- OpenPlaceboCycling
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Open-placebo Intervention on Cycling Time-trial Performance
- ClinicalTrials.gov ID
- NCT03977246
- Acronym / sponsor ID
- OpenPlaceboCycling
- Conditions
- Exercise Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of an open-label placebo intervention on cycling time-trial performance.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-placebo | Experimental | Behavioral: Open-placeboThe open-placebo intervention session |
| Control | Placebo comparator | Behavioral: ControlThe control session |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females aged between 18 and 45 years old;
- A minimum of one-year training experience in cycling.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-placeboApplication of the open-placebo intervention | Behavioural | Open-placebo |
| ControlApplication of the control session | Behavioural | Control |
Primary outcome
Exercise performance
Time frame: 20-min following open-placebo intervention
Change in 1 km cycling time-trial performance
1 secondary outcome
Blood lactate
Time frame: Immediately post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gualano, PhD principal investigator
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Exercise Performance, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise performance (time frame: 20-min following open-placebo intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.