HealthyNCT05573971
Verbal Encouragement in Swimming
A study testing with verbal encouragement in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
Trial summary
Verbal encouragement (VE) is used to enhance the performance in several sports, even though no studies have been conducted in swimmers and no effects have been reported in elite athletes by some Authors. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- with verbal encouragement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2021to 29 Sep 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least 1 year of experience in training aimed at regional and international competitions
- a score ≥ 200 points on the personal best in the 200m freestyle, in accordance with the international point score (IPS) (http://www. swimnews.com/ipspoints)
- being healthy
Who cannot join
- having a disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Verbal Encouragement on Performance and Muscle Fatigue in Swimming
Verbal encouragement (VE) is used to enhance the performance in several sports, even though no studies have been conducted in swimmers and no effects have been reported in elite athletes by some Authors. Besides influencing motor performance, VE is also known to enhance the physical load, thus increasing the probability of developing fatigue. The aim of this research was to study VE in swimmers by evaluating both chronometric performance and muscle fatigue (using sEMG).
- Conditions
- Healthy
- Being tested
- with verbal encouragement
- Keywords
- verbal encouragement, performance, muscle fatigue, swimming, sEMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with verbal encouragementOther
Each athlete swam a maximal 200m freestyle trial in two different conditions: one trial with verbal encouragement and the other without verbal encouragement
| Study group | Role | What they receive |
|---|---|---|
| with verbal encouragement | Experimental | Not described Receives: Other: with verbal encouragement |
| without verbal encouragement | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
swimming velocity
m/sec
Measured: up to 2min 30s
Secondary outcomes (4)
Pectoralis Major muscle fatigue
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Pectoralis Major muscle
Measured: up to 2min 30s
Triceps Brachii muscle fatigue
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Triceps Brachii muscle
Measured: up to 2min 30s
Latissimus Dorsi muscle fatigue
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Latissimus Dorsi muscle
Measured: up to 2min 30s
Rectus Femoris muscle fatigue
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Rectus Femoris muscle
Measured: up to 2min 30s
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start2 Feb 2021
- Primary completion7 Mar 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita degli Studi di Genova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Puce, Universita degli Studi di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573971
- Sponsor's protocol ID
- VES-DINOGMI-21
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 10 Oct 2022
- 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 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Verbal Encouragement on Performance and Muscle Fatigue in Swimming
- ClinicalTrials.gov ID
- NCT05573971
- Acronym / sponsor ID
- VES-DINOGMI-21
- Conditions
- Healthy
- Keywords
- verbal encouragement, performance, muscle fatigue, swimming, sEMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 7 Mar 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 10 Oct 2022 (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.
Verbal encouragement (VE) is used to enhance the performance in several sports, even though no studies have been conducted in swimmers and no effects have been reported in elite athletes by some Authors. Besides influencing motor performance, VE is also known to enhance the physical load, thus increasing the probability of developing fatigue. The aim of this research was to study VE in swimmers by evaluating both chronometric performance and muscle fatigue (using sEMG).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with verbal encouragement | Experimental | Other: with verbal encouragement |
| without verbal encouragement | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- at least 1 year of experience in training aimed at regional and international competitions
- a score ≥ 200 points on the personal best in the 200m freestyle, in accordance with the international point score (IPS) (http://www. swimnews.com/ipspoints)
- being healthy
Key exclusion criteria (1 listed)
- having a disease
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 |
|---|---|---|
| with verbal encouragementEach athlete swam a maximal 200m freestyle trial in two different conditions: one trial with verbal encouragement and the other without verbal encouragement | Other | with verbal encouragement |
Primary outcome
swimming velocity
Time frame: up to 2min 30s
m/sec
4 secondary outcomes
Pectoralis Major muscle fatigue
Time frame: up to 2min 30s
Triceps Brachii muscle fatigue
Time frame: up to 2min 30s
Latissimus Dorsi muscle fatigue
Time frame: up to 2min 30s
Rectus Femoris muscle fatigue
Time frame: up to 2min 30s
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 10 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with verbal encouragement in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
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 3 inclusion and 1 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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. 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?
swimming velocity (time frame: up to 2min 30s). 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 10 Oct 2022.