Clinical trial NCT03506282: Does Listening to Music Alter the Running Mechanics?
Official title: The Effects of Listening to Music During Running on Ground Contact Forces and Running Mechanics: the "IMPACT Factor" Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Keywords: Running biomechanics
Vertical loading rate
Music exercise
Gait analysis
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Average ground pressure force
timeFrame: 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 outcomes:
measure: Peak ground pressure force
timeFrame: 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.
measure: Average vertical loading rate
timeFrame: 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.
measure: Stride length
timeFrame: 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.
measure: Stride time
timeFrame: 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.
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Department of Biomedical Sciences- University of Sassari
state: Sassari (SS)
city: Sassari
country: Italy
facility: University of Sassari
Study officials:
affiliation: University of Sassari, Department of Biomedical Sciences
name: Manca Andrea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sassari, Department of Biomedical Sciences
name: Franca Deriu, PhD
role: STUDY_DIRECTOR
affiliation: University of Cagliari, Department of Medical Sciences and Public Health
name: Lucia Cugusi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Esercizio Vita Medical Fitness
name: Pomidori Luca, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Esercizio Vita Medical Fitness
name: Felisatti Michele, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.