HealthyNCT06408155
Improvement of Motor Tasks: Effects of Verbal Encouragement and Music
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 employed a randomized crossover design to assess the impacts of three different experimental conditions-standard environment, music, and verbal encouragement-on performance in an isometric endurance task, with comparisons made between untrained and trained individuals. Read more about this study
- Who is it for?
- Ages 25 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
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2024to 6 Jun 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health,
- No medical conditions that could interfere with their ability to perform the test safely and effectively.
- To be considered exercised, participants had to have performed 150 minutes per week of vigorous intensity aerobic physical activity, in addition to muscle strengthening activities, for at least two days per week. Those who did not meet this standard were considered untrained.
Who cannot join
- History of surgery on the arm, shoulder or adjacent areas that could limit the ability to perform the test.
- Use of medication that affects muscle function or pain perception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improvement of Motor Tasks Performance: Effects of Verbal Encouragement and Music - Key Results From a Randomised Crossover Study With Electromyography
This study employed a randomized crossover design to assess the impacts of three different experimental conditions-standard environment, music, and verbal encouragement-on performance in an isometric endurance task, with comparisons made between untrained and trained individuals. Interventions were spaced seven days apart. Measurements included muscle activity and fatigue, assessed via surface electromyography, and the duration of the task.
The isometric endurance task required participants to maintain a 90° elbow flexion while holding a dumbbell in a supine grip, weighted to 80% of their one-repetition maximum, on the dominant side. During the task, participants were to keep their back and head against a vertical wall, stand with feet shoulder-width apart, and firmly on the ground. The dumbbell was held with the dominant arm, and the other arm was kept neutral by the side. It was crucial to avoid any rocking or movements that would ease maintaining the position. The test began when the bar was handed to the participant in the correct stance and concluded once the arm's angle deviated by more than five degrees from the start.
- Conditions
- Healthy
- Being tested
- Isometric Task
- Keywords
- motor recruitment, motivation, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric TaskOther
The task demanded that participants maintain their arm bent at a 90° angle while holding a dumbbell, which weighed 80% of their one-repetition maximum (1RM), in a supine grip on the dominant side of their body for the longest time they could.
| Study group | Role | What they receive |
|---|---|---|
| Task with verbal encouragement | Experimental | Endurance isometric exercise performed with verbal encouragement Receives: Other: Isometric Task |
| Task 1 without motivational feedback | Active comparator | Task without motivational feedback Receives: Other: Isometric Task |
| Task with music | Experimental | Endurance isometric exercise performed with music Receives: Other: Isometric Task |
| Task 2 without motivational feedback | Active comparator | 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: Through task completion, an average of sixty seconds
Neuromuscular excitation of Biceps Brachii
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle
Measured: Through task completion, an average of sixty seconds
Neuromuscular excitation of Brachioradialis
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Brachioradialis muscle
Measured: Through task completion, an average of sixty seconds
Neuromuscular fatigue of Biceps Brachii
Time-course evolution of the Median Frequency of the Power Density Spectrum (MF Hz) of the electromyography signal measured for biceps brachii muscle
Measured: Through task completion, an average of sixty seconds
Neuromuscular fatigue of Brachioradialis
Time-course evolution of the Median Frequency of the Power Density Spectrum (MF Hz) of the electromyography signal measured for Brachioradialis muscle
Measured: Through task completion, an average of sixty seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start13 Apr 2024
- Primary completion1 Jun 2024
- Study completion6 Jun 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
- 30 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
- NCT06408155
- Sponsor's protocol ID
- DINOGMI-2024
- Status last verified
- Jun 2024
- First submitted
- 6 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Motor Tasks Performance: Effects of Verbal Encouragement and Music - Key Results From a Randomised Crossover Study With Electromyography
- ClinicalTrials.gov ID
- NCT06408155
- Acronym / sponsor ID
- DINOGMI-2024
- Conditions
- Healthy
- Keywords
- motor recruitment, motivation, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universita degli Studi di GenovaUniversity, hospital or other
- Study start
- 13 Apr 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 9 May 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 employed a randomized crossover design to assess the impacts of three different experimental conditions-standard environment, music, and verbal encouragement-on performance in an isometric endurance task, with comparisons made between untrained and trained individuals. Interventions were spaced seven days apart. Measurements included muscle activity and fatigue, assessed via surface electromyography, and the duration of the task.
The isometric endurance task required participants to maintain a 90° elbow flexion while holding a dumbbell in a supine grip, weighted to 80% of their one-repetition maximum, on the dominant side. During the task, participants were to keep their back and head against a vertical wall, stand with feet shoulder-width apart, and firmly on the ground. The dumbbell was held with the dominant arm, and the other arm was kept neutral by the side. It was crucial to avoid any rocking or movements that would ease maintaining the position. The test began when the bar was handed to the participant in the correct stance and concluded once the arm's angle deviated by more than five degrees from the start.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Task with verbal encouragement | Experimental | Other: Isometric TaskEndurance isometric exercise performed with verbal encouragement |
| Task 1 without motivational feedback | Active comparator | Other: Isometric TaskTask without motivational feedback |
| Task with music | Experimental | Other: Isometric TaskEndurance isometric exercise performed with music |
| Task 2 without motivational feedback | Active comparator | Other: Isometric TaskTask without motivational feedback |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general health,
- No medical conditions that could interfere with their ability to perform the test safely and effectively.
- To be considered exercised, participants had to have performed 150 minutes per week of vigorous intensity aerobic physical activity, in addition to muscle strengthening activities, for at least two days per week. Those who did not meet this standard were considered untrained.
Key exclusion criteria (2 listed)
- History of surgery on the arm, shoulder or adjacent areas that could limit the ability to perform the test.
- Use of medication that affects muscle function or pain perception
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 task demanded that participants maintain their arm bent at a 90° angle while holding a dumbbell, which weighed 80% of their one-repetition maximum (1RM), in a supine grip on the dominant side of their body for the longest time they could. | Other | Task 1 without motivational feedback, Task 2 without motivational feedback, Task with music, Task with verbal encouragement |
Primary outcome
Duration of the task
Time frame: Through task completion, an average of sixty seconds
task duration expressed in seconds
Neuromuscular excitation of Biceps Brachii
Time frame: Through task completion, an average of sixty seconds
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Biceps Brachii muscle
Neuromuscular excitation of Brachioradialis
Time frame: Through task completion, an average of sixty seconds
Amplitude of electromyography value (Root Mean Square in microvolt) measured for Brachioradialis muscle
Neuromuscular fatigue of Biceps Brachii
Time frame: Through task completion, an average of sixty seconds
Time-course evolution of the Median Frequency of the Power Density Spectrum (MF Hz) of the electromyography signal measured for biceps brachii muscle
Neuromuscular fatigue of Brachioradialis
Time frame: Through task completion, an average of sixty seconds
Time-course evolution of the Median Frequency of the Power Density Spectrum (MF Hz) of the electromyography signal measured for Brachioradialis 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 7 Jun 2024.
- Individual participant dataSharing planned: Yes
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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 3 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 7 Jun 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: Through task completion, an average of sixty 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 7 Jun 2024.