NCT06380088

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2022

Typical duration 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

July 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1.1 years

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

muscle fatigueNeuromuscular StrategyperformancesEMGMotor recruitmentMotivation

Outcome Measures

Primary Outcomes (5)

  • Duration of the task

    task duration expressed in seconds

    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

    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

    60 seconds

  • Biceps Brachii activity

    time-course evolution of the amplitude (Root Mean Square \[microvolt\]) of the sEMG signal measured for Biceps Brachii muscle

    60 seconds

  • Triceps Brachii activity

    time-course evolution of the amplitude (Root Mean Square \[microvolt\]) of the sEMG signal measured for Triceps Brachii muscle

    60 seconds

Study Arms (3)

Task with music

EXPERIMENTAL

Endurance isometric exercise performed to selected music.

Other: Isometric Task

Task with verbal encouragement

EXPERIMENTAL

Endurance isometric exercise performed with verbal encouragement.

Other: Isometric Task

Task without motivational feedback

EXPERIMENTAL

Task without motivational feedback.

Other: Isometric Task

Interventions

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.

Task with musicTask with verbal encouragementTask without motivational feedback

Eligibility Criteria

Age27 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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

April 18, 2024

First Posted

April 23, 2024

Study Start

July 1, 2022

Primary Completion

August 5, 2023

Study Completion

March 15, 2024

Last Updated

April 23, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations