NCT03506282

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
7mo left

Started Jul 2018

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jul 2018Dec 2026

First Submitted

Initial submission to the registry

April 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

8.5 years

First QC Date

April 13, 2018

Last Update Submit

April 29, 2026

Conditions

Keywords

Running biomechanicsVertical loading rateMusic exerciseGait analysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Peak ground pressure force

    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.

  • Average vertical loading rate

    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.

  • Stride length

    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.

  • Stride time

    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.

Study Arms (4)

No music

NO INTERVENTION

The participants will be required to run on a treadmill at 3 different speeds (6-8-10 km/h) with no music.

Traffic audio track

ACTIVE COMPARATOR

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

Music at moderate volume

EXPERIMENTAL

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

Music at moderate-to-high volume

EXPERIMENTAL

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

Interventions

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).

Also known as: Traffic audio track
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 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).

Also known as: Music at moderate volume
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-to-high volume (85 dB).

Also known as: Music at moderate-to-high volume
Music at moderate-to-high volume

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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:
  • or more days of vigorous activity of at least 20 minutes per day OR
  • or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR
  • 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.

You may not qualify if:

  • Past or present diseases of the auditory and vestibular system (as assessed by otolaryngological and audiometric examinations).
  • Traumatology/orthopedic conditions that contraindicate treadmill training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Biomedical Sciences- University of Sassari

Sassari, Sassari (SS), 07100, Italy

RECRUITING

University of Sassari

Sassari, Sassari, 07100, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32277258BACKGROUND
  • 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.

    PMID: 32997258BACKGROUND

Related Links

MeSH Terms

Interventions

Running

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Manca Andrea, PhD

    University of Sassari, Department of Biomedical Sciences

    PRINCIPAL INVESTIGATOR
  • Franca Deriu, PhD

    University of Sassari, Department of Biomedical Sciences

    STUDY DIRECTOR
  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manca Andrea, PhD

CONTACT

Michele Felisatti, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2018

First Posted

April 24, 2018

Study Start

July 15, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations