NCT06408155

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

May 6, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

motor recruitmentmotivationperformance

Outcome Measures

Primary Outcomes (5)

  • Duration of the task

    task duration expressed in seconds

    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

    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

    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

    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

    Through task completion, an average of sixty seconds

Study Arms (4)

Task with verbal encouragement

EXPERIMENTAL

Endurance isometric exercise performed with verbal encouragement

Other: Isometric Task

Task 1 without motivational feedback

ACTIVE COMPARATOR

Task without motivational feedback

Other: Isometric Task

Task with music

EXPERIMENTAL

Endurance isometric exercise performed with music

Other: Isometric Task

Task 2 without motivational feedback

ACTIVE COMPARATOR

Task without motivational feedback

Other: Isometric Task

Interventions

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.

Task 1 without motivational feedbackTask 2 without motivational feedbackTask with musicTask with verbal encouragement

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Genova

Genova, 16122, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2024

First Posted

May 9, 2024

Study Start

April 13, 2024

Primary Completion

June 1, 2024

Study Completion

June 6, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Locations