HealthyNCT06380088
Improving Motor Skills: The Role of Music and Encouragement
A study testing Isometric Task in people with Healthy, run by Universita degli Studi di Genova at 1 site in Italy.
Trial summary
This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. Read more about this study
- Who is it for?
- Ages 27 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Isometric Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2022to 15 Mar 2024
- 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 27 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in the study, candidates had to be in good general health, with no medical conditions that could interfere with their ability to perform the test safely and effectively. In addition, to be considered trained, participants had to have performed 150 minutes per week of vigorous-intensity aerobic physical activity, in addition to muscle-strengthening activities, on at least two days per week. Those who did not meet this standard were considered untrained.
- -
Who cannot join
- Exclusion criteria included a history of surgery to the arm, shoulder, or nearby areas that could limit the ability to perform the test. The use of medications that affect muscle function or pain perception was also a reason for exclusion, so that the test results could not be influenced by external factors.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Motor Task Performance: Music and Verbal Encouragement as Catalysts - Highlights From Electromyographic Analysis
This study used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.
Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position.
- Conditions
- Healthy
- Being tested
- Isometric Task
- Keywords
- muscle fatigue, Neuromuscular Strategy, performance, sEMG, Motor recruitment, Motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric TaskOther
The exercise required participants to keep their arm flexed at a 90° angle while holding a dumbbell loaded to 80% of their 1RM (One Rep Max) in a supine position on the dominant side of the body for as long as possible.
| Study group | Role | What they receive |
|---|---|---|
| Task with music | Experimental | Endurance isometric exercise performed to selected music. Receives: Other: Isometric Task |
| Task with verbal encouragement | Experimental | Endurance isometric exercise performed with verbal encouragement. Receives: Other: Isometric Task |
| Task without motivational feedback | Experimental | Task without motivational feedback. Receives: Other: Isometric Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the task
task duration expressed in seconds
Measured: 60 seconds
Biceps Brachii muscle fatigue
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Biceps Brachii muscle
Measured: 60 seconds
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: 60 seconds
Biceps Brachii activity
time-course evolution of the amplitude (Root Mean Square [microvolt]) of the sEMG signal measured for Biceps Brachii muscle
Measured: 60 seconds
Triceps Brachii activity
time-course evolution of the amplitude (Root Mean Square [microvolt]) of the sEMG signal measured for Triceps Brachii muscle
Measured: 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jul 2022
- Primary completion5 Aug 2023
- Study completion15 Mar 2024
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
- 25 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
- NCT06380088
- Sponsor's protocol ID
- VEM-DINOGMI-24
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Motor Task Performance: Music and Verbal Encouragement as Catalysts - Highlights From Electromyographic Analysis
- ClinicalTrials.gov ID
- NCT06380088
- Acronym / sponsor ID
- VEM-DINOGMI-24
- Conditions
- Healthy
- Keywords
- muscle fatigue, Neuromuscular Strategy, performance, sEMG, Motor recruitment, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 23 Apr 2024 (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 used a randomised crossover design to analyse the effect of three different experimental interventions - i.e. standard conditions, music and verbal encouragement - on performance in an isometric endurance task, comparing results between untrained and trained individuals. The interval between each intervention was set at seven days. The outcome measures are muscle activity and fatigue, assessed by surface electromyography, and task duration.
Isometric endurance task requires participants to keep their arm flexed at a 90° angle while holding a dumbbell with a supine grip loaded to 80% of 1RM on the dominant side of the body. During execution, the back and head should remain in contact with a vertical wall, with the feet shoulder width apart and firmly planted on the floor. The bar is held with the dominant arm while the other arm remains in a neutral position close to the body. It is imperative to avoid any form of rocking or movement that would make it easier to maintain the position. The test officially begins when the bar is handed to the subject, who is already in the correct position, and ends as soon as the angle of the arm varies by more than five degrees from the starting position.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Task with music | Experimental | Other: Isometric TaskEndurance isometric exercise performed to selected music. |
| Task with verbal encouragement | Experimental | Other: Isometric TaskEndurance isometric exercise performed with verbal encouragement. |
| Task without motivational feedback | Experimental | Other: Isometric TaskTask without motivational feedback. |
Who may qualify
- Ages
- 27 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To be included in the study, candidates had to be in good general health, with no medical conditions that could interfere with their ability to perform the test safely and effectively. In addition, to be considered trained, participants had to have performed 150 minutes per week of vigorous-intensity aerobic physical activity, in addition to muscle-strengthening activities, on at least two days per week. Those who did not meet this standard were considered untrained.
- -
Key exclusion criteria (2 listed)
- Exclusion criteria included a history of surgery to the arm, shoulder, or nearby areas that could limit the ability to perform the test. The use of medications that affect muscle function or pain perception was also a reason for exclusion, so that the test results could not be influenced by external factors.
- -
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 |
|---|---|---|
| Isometric TaskThe exercise required participants to keep their arm flexed at a 90° angle while holding a dumbbell loaded to 80% of their 1RM (One Rep Max) in a supine position on the dominant side of the body for as long as possible. | Other | Task with music, Task with verbal encouragement, Task without motivational feedback |
Primary outcome
Duration of the task
Time frame: 60 seconds
task duration expressed in seconds
Biceps Brachii muscle fatigue
Time frame: 60 seconds
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Biceps Brachii muscle
Triceps Brachii muscle fatigue
Time frame: 60 seconds
time-course evolution of the median frequency of the power density spectrum (MF [Hz]) of the sEMG signal measured for Triceps Brachii muscle
Biceps Brachii activity
Time frame: 60 seconds
time-course evolution of the amplitude (Root Mean Square [microvolt]) of the sEMG signal measured for Biceps Brachii muscle
Triceps Brachii activity
Time frame: 60 seconds
time-course evolution of the amplitude (Root Mean Square [microvolt]) of the sEMG signal measured for Triceps Brachii muscle
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 23 Apr 2024.
- 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 Isometric Task 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 2 inclusion and 2 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 23 Apr 2024. 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?
Duration of the task (time frame: 60 seconds). The study lists 5 primary outcomes in all. 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 23 Apr 2024.