COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Listening to Music Alter the Running Mechanics?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03506282
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Franca Deriu, Università degli Studi di Sassari

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Other: Running while listening to a traffic audio track Other: Running with music at moderate volume Other: Running with music at moderate-to-high volume Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

The experimental conditions to be tested in each subject will be: 0, running with no music; 1, running and listening to audio track resembling normal outdoor noise (70 dB); 2, running with music at moderate volume (80 dB); 3, running with music at moderate to high volume (85 dB). The experimental conditions will be carried out in random order, with a wash-out period of 10 minutes, to ensure the return to the auditory and vestibular baseline.

Depending on the random sequence generated, the subject will undergo the four conditions in the specified order. Each condition will be completed with the three steps lasting 2 mins each (A, running at 6 km/h; B, running at 8 km/h; C, running at 10 km/h) and carried out at 1-min time interval in between, before proceeding to the next one. A complete rest of 10 minutes will be allowed among the conditions to restore the physiological state of the auditory and vestibular systems and to recover from the submaximal running effort.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The participants and the research assistant operator who will deliver the experimental conditions will not be masked to the condition whilst the outcome assessor, the statistician and the principal investigator will be blinded.
Primary Purpose: Prevention
Official Title: The Effects of Listening to Music During Running on Ground Contact Forces and Running Mechanics: the "IMPACT Factor" Trial
Actual Study Start Date : July 15, 2018
Actual Primary Completion Date : April 15, 2019
Estimated Study Completion Date : July 31, 2021

Arm Intervention/treatment
No Intervention: No music
The participants will be required to run on a treadmill at 3 different speeds (6-8-10 km/h) with no music.
Active Comparator: Traffic audio track
In addition to running on the treadmill, participants will be listening to an audio track resembling normal outdoor noise (70 dB) through earphones connected to a mobile phone.
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).
Other Name: Traffic audio track

Experimental: Music at moderate volume
In addition to running on the treadmill, participants will be listening to music at a moderate volume (80 dB) through earphones connected to a mobile phone.
Other: 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).
Other Name: Music at moderate volume

Experimental: Music at moderate-to-high volume
In addition to running on the treadmill, participants will be listening to music at a moderate-to-high volume (85 dB) through earphones connected to a mobile phone.
Other: 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).
Other Name: Music at moderate-to-high volume




Primary Outcome Measures :
  1. Average ground pressure force [ Time Frame: 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. ]
    This outcome expresses the mean amount of impact recorded by the force plates embedded in the treadmill.


Secondary Outcome Measures :
  1. Peak ground pressure force [ Time Frame: 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. ]
    This outcome expresses the highest amount of impact recorded by the force plates embedded in the treadmill.

  2. Average vertical loading rate [ Time Frame: 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. ]
    This outcome expresses the vertical oscillation of the center of mass and is considered highly linked to the risk of injury.

  3. Stride length [ Time Frame: 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. ]
    The stride length is the distance between two successive placements of the same foot.

  4. Stride time [ Time Frame: 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. ]
    It is the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in milliseconds.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506282


Contacts
Layout table for location contacts
Contact: Manca Andrea, PhD +39 079228154 andmanca@uniss.it
Contact: Michele Felisatti, PhD +39 349 8054363 m.felisatti@eserciziovita.it

Locations
Layout table for location information
Italy
Department of Biomedical Sciences- University of Sassari Recruiting
Sassari, Sassari (SS), Italy, 07100
Contact: Andrea Manca, PhD    +39 079228294    andmanca@uniss.it   
Principal Investigator: Franca Deriu, MD; PhD         
Principal Investigator: Andrea Manca, MSc; PhD         
Principal Investigator: Pomidori Luca, MSc; PhD         
Principal Investigator: Felisatti Michele, MSc; PhD         
Principal Investigator: Cugusi Lucia, MSc; PhD         
Sub-Investigator: Altavilla Giorgio, MSc         
Sub-Investigator: Zocca Eleonora, BSc         
Sub-Investigator: Zocca Martina, BSc         
University of Sassari Recruiting
Sassari, Italy, 07100
Contact: Andrea Manca, PhD    +39 079228154    andmanca@uniss.it   
Sponsors and Collaborators
Università degli Studi di Sassari
Investigators
Layout table for investigator information
Principal Investigator: Manca Andrea, PhD University of Sassari, Department of Biomedical Sciences
Study Director: Franca Deriu, PhD University of Sassari, Department of Biomedical Sciences
Principal Investigator: Lucia Cugusi, PhD University of Cagliari, Department of Medical Sciences and Public Health
Principal Investigator: Pomidori Luca, PhD Esercizio Vita Medical Fitness
Principal Investigator: Felisatti Michele, PhD Esercizio Vita Medical Fitness
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Professor Franca Deriu, Associate Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT03506282    
Other Study ID Numbers: USassari
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Franca Deriu, Università degli Studi di Sassari:
Running biomechanics
Vertical loading rate
Music exercise
Gait analysis