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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03506282
Other study ID # USassari
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2018
Est. completion date December 31, 2023

Study information

Verified date May 2023
Source Università degli Studi di Sassari
Contact Manca Andrea, PhD
Phone +39 079228154
Email andmanca@uniss.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether in healthy subjects listening to music while running influences the ground pressure forces, the vertical loading and, overall, the running biomechanics.


Description:

The analysis of the effects that listening to music may exert during exercise has been the topic of a number of scientific articles. Overall, these studies documented how music influences performance and they generally observed positive effects. The majority of the investigations were carried out in the aerobic/endurance domain where music was found to enhance running performance and is also likely to accelerate heart rate recovery after strenuous exercise, albeit not all the authors agree on this point. It has been also reported that loud music not only enhances optimal exercising, but also interacts with music tempo to yield significant additional performance benefits. Despite such interesting findings, the focus of these investigations was restricted to characterize the physiological responses that individuals exhibit when listening to music during physical activity, mainly running. Thus, the studies ended up with positive results, that is, increased performance, or failed in showing any effect. Beside the above reported positive effects of music some potentially negative effects should be considered. First, regardless of whether running is included or not in the experimental condition, exposure to high levels of noise/sound even for short periods of time can be damaging for the auditory system, possibly resulting in hearing loss or impairment. This topic has been scrutinized by a number of studies, with a specific attention to adolescent populations who are exposed to high risk of hearing problems due to the massive usage of listening devices. Although this is a crucial issue, such source of hazard can be adequately controlled for by firmly sticking to the guidelines on the recommended exposure limits (REL), which is recommended by the National Institute for Occupational Safety and Health (NIOSH). The REL has been set at 85 decibels (dB) for a maximum of 8 hours. Increasing the volume by rate of 3 dB increases the risk exponentially. For instance, a noise corresponding to an intensity of 88 dB should not exceed an exposure of 4 hours, then 91 dB 2 hours, 94 dB 1 hour, 97 dB 30 minutes, 100 dB 15 minutes, 103 dB 7.5 minutes, 106 dB 3.7 minutes and so on, up to 140 dB, which must not be provided at all. Surprisingly, to date and to our knowledge, the influence that listening to music with portable devices and earphones may exert on the amount of vertical force upon impact loading during running has not been investigated yet. Unlike the considerable number of previous works which were focused on the physiological and psychological responses to music during exercise, no references that attempted to address the biomechanical consequences of music listening on impact loading and jogging/running mechanics could be traced in the literature. Therefore, our main goal is to fill this gap in the existing literature. Considering the universal widespread and popularity of running and that approximately 47 million Americans participated in running activities in the last decade, the findings generated by this research would be highly relevant to the broad field of sports medicine and exercise science.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Healthy subjects - Age 18-35 years - Level of fitness: Moderate level (ACTIVE) according to the classification of the American College of Sports Medicine depicting "Moderate" as either of the following 3 criteria: - 3 or more days of vigorous activity of at least 20 minutes per day OR - 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR - 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 metabolic equivalents (METs) per week. - able to run on a treadmill safely and without bilateral or unilateral support. Exclusion Criteria: - Past or present diseases of the auditory and vestibular system (as assessed by otolaryngological and audiometric examinations). - Traumatology/orthopedic conditions that contraindicate treadmill training.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Running while listening to a traffic audio track
While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be exposed via earphones to an audio track resembling average outdoor conditions (70 dB).
Running with music at moderate volume
While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be provided the same music track ("We take care of our own", by Bruce Springsteen from the "Wrecking Ball" album, 2012). The music track will be given at a moderate volume (80 dB).
Running with music at moderate-to-high volume
While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be provided the same music track ("We take care of our own", by Bruce Springsteen from the "Wrecking Ball" album, 2012). The music track will be given at a moderate-to-high volume (85 dB).

Locations

Country Name City State
Italy Department of Biomedical Sciences- University of Sassari Sassari Sassari (SS)
Italy University of Sassari Sassari

Sponsors (1)

Lead Sponsor Collaborator
Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Manca A, Cugusi L, Behm D, Dvir Z, Ferber R, Deriu F. More on "listening to music while running alters ground reaction forces": why women and men pound the ground differently? Eur J Appl Physiol. 2021 Jan;121(1):351-352. doi: 10.1007/s00421-020-04517-z. Epub 2020 Sep 30. No abstract available. — View Citation

Manca A, Cugusi L, Pomidori L, Felisatti M, Altavilla G, Zocca E, Zocca M, Bussu F, Dvir Z, Deriu F. Listening to music while running alters ground reaction forces: a study of acute exposure to varying speed and loudness levels in young women and men. Eur J Appl Physiol. 2020 Jun;120(6):1391-1401. doi: 10.1007/s00421-020-04371-z. Epub 2020 Apr 10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Average ground pressure force This outcome expresses the mean amount of impact recorded by the force plates embedded in the treadmill. It will be assessed for each participant and for each arm of the study during the three 2-minute runs on the treadmill through study completion, an average of 1 year.
Secondary Peak ground pressure force This outcome expresses the highest amount of impact recorded by the force plates embedded in the treadmill. It will be assessed for each participant and for each arm of the study during the three 2-minute runs on the treadmill through study completion, an average of 1 year.
Secondary Average vertical loading rate This outcome expresses the vertical oscillation of the center of mass and is considered highly linked to the risk of injury. It will be assessed for each participant and for each arm of the study during the three 2-minute runs on the treadmill through study completion, an average of 1 year.
Secondary Stride length The stride length is the distance between two successive placements of the same foot. It will be assessed for each participant and for each arm of the study during the three 2-minute runs on the treadmill through study completion, an average of 1 year.
Secondary Stride time It is the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in milliseconds. It will be assessed for each participant and for each arm of the study during the three 2-minute runs on the treadmill through study completion, an average of 1 year.
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