The Effect of Different Acoustic Conditions on 6-Minute Walk Test Performance and Recovery

NCT07540455 | Not Yet Recruiting

• 1 other identifier: Different Acoustic Condition
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design: Randomized Cross-Over Study Objective: This study aims to compare the acute effects of three different auditory conditions (metronome, binaural beats, and silent control) on 6-Minute Walk Test (6MWT) performance, post-exercise recovery physiology, and perceived exertion in healthy young adults. Background: Auditory-motor coupling mechanisms suggest that rhythmic auditory stimuli can lower the excitation threshold of motor neurons, thereby enhancing walking efficiency. Rhythmic stimuli such as metronomes are known to improve walking speed and coordination. Binaural beats are an auditory stimulus type generated by presenting two tones of slightly different frequencies to each ear, triggering cortical neural entrainment. It has been reported that listening to binaural beats at theta frequency following exercise increases parasympathetic activation and accelerates recovery. This study aims to examine these two auditory stimuli in comparison with a control condition in healthy young adults. Participants: Healthy young adults aged 18-35 who can walk independently and have no cardiovascular, pulmonary, neurological, or musculoskeletal conditions. Minimum sample size will be calculated using G\*Power following a pilot study, with a 20% dropout margin added. Randomization: All participants will be exposed to all three conditions on separate days. The order of application will be determined by computer-based simple randomization (randomizer.org). Six possible sequence combinations will be used to balance order effects. A washout period of at least 24 hours will be applied between sessions. Interventions: Metronome Condition: Each participant's natural walking cadence will be measured, and the metronome tempo will be set at 110% of this baseline value. Binaural Beats Condition: A carrier frequency of 120 Hz will be delivered to the right ear and 100 Hz to the left ear, generating a 20 Hz binaural beat in the Beta frequency band. Participants will listen for 6 minutes at rest immediately before the walking test. Control Condition: No auditory stimulus will be applied. The 6MWT will be conducted in all conditions along a 30-meter flat corridor in accordance with ATS/ERS standards. Measurement Time Points: Pre-test, immediately post-test, and at the 1st, 3rd, and 5th minutes of the recovery period. Outcome Measures: Primary: Total distance covered during 6MWT (meters), walking cadence (steps/min) Secondary: Heart rate, blood pressure, peripheral oxygen saturation (SpO₂), perceived dyspnea, general fatigue, and quadriceps femoris muscle fatigue assessed via the Modified Borg Scale Statistical Analysis: One-Way Repeated Measures ANOVA for walking distance and cadence; Two-Way Repeated Measures ANOVA (condition × time) for physiological parameters; Friedman test for Borg scale data; Bonferroni-corrected post-hoc tests where significant differences are found. Significance level set at p\<0.05. Study Duration: April - June 2026 (3 months)

Conditions

Recovery; Fatigue Recovery; Healhty

Keywords

6 minutes walk test; metronome; binaural; recovery

Outcome Measures

Primary Outcomes (2)

• 6 minutes walk distance

  In the study, the 6-Minute Walk Test (6MWT) will be administered in accordance with ATS/ERS standards to objectively assess participants' functional exercise capacity. The test will be conducted in a flat, marked corridor 30 metres in length, where emergency equipment is readily accessible. Prior to the procedure, participants will rest for 10 minutes, during which their baseline heart rate, blood pressure, oxygen saturation (SpO2), and levels of breathlessness, general fatigue, and quadriceps femoris muscle fatigue will be measured using the Modified Borg Scale and recorded. During the test, the participant will be asked to cover the longest distance possible at their own pace without running for 6 minutes; standard verbal encouragement will be provided every minute, and the participant will be permitted to rest without stopping the timer if necessary.

  24-48-hour period

• Cadence

  In the study, walking cadence will be measured to assess participants' walking dynamics and exercise efficiency. During the fourth minute of the 6DYT test, the researcher will count and record the number of steps taken by the participant over a one-minute period. (Deboeck et al.,2005).

  24-48-hour period

Secondary Outcomes (6)

• Heart rate

  24-48-hour period

• Peripheral Oxygen Saturation

  24-48-hour period

• Blood Pressure

  24-48-hour period

• Dyspnea

  24-48-hour period

• Fatigue

  24-48-hour period

Study Arms (3)

Metronome

They will complete the 6-minute walk test whilst listening to a metronome.

Other: Metronome

Binaural beats

They will complete the 6-minute walk test whilst listening to binaural beats.

Other: Bineural Beats

Control

They will complete the 6-minute walk test without any additional auditory conditions.

Other: Control

Interventions

Metronome OTHER

A 30-second preliminary walking assessment will be conducted to objectively determine participants' natural cadence. During this assessment, participants will be asked to walk at their preferred comfortable pace, and the number of steps taken over the 30-second period will be counted and recorded by the researcher. This value will be multiplied by two to calculate the participant's 1-minute baseline walking cadence (steps per minute) (Chase et al., 2023). In accordance with our study protocol, the speed of the Rhythmic Auditory Stimulus (metronome) accompanying the test has been standardised to be 10% above the patient's own rhythm (Yu et al., 2015). Accordingly, the calculated baseline walking cadence will be multiplied by a factor of 1.10 to obtain the target metronome rhythm (BPM - beats per minute).

Metronome

Bineural Beats OTHER

Binaural sound is a safe auditory stimulation method based on the principle of presenting two distinct pure tones at different frequencies to both ears simultaneously, allowing the brain to perceive the frequency difference between these two tones. Within this protocol, carrier frequencies in the 100-120 Hz range-which are physiologically safe and well-tolerated by the human ear-will be used. The mathematical difference between these carrier frequencies delivered to the participant's right and left ears will stimulate the brain at the target frequency. To ensure the anatomical feasibility of the binaural illusion and to provide sound isolation, the prepared standard audio file will be played to participants via headphones (Chaieb et al., 2015). Furthermore, the literature indicates that a specific preparation period is required for binaural stimulation to facilitate adaptation at the neurological level and to fully demonstrate the targeted cortical activity (Gao et al., 2014). Accordin

Binaural beats

Control OTHER

The 6-minute walk test will be completed without any auditory cues.

Control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of healthy young adults aged 18-35 living or studying in Gaziantep, Turkey. Participants will be recruited from students and staff at Hasan Kalyoncu University who meet the inclusion criteria. All participants must be able to walk independently without an assistive device and must provide signed informed consent. Individuals with cardiovascular, pulmonary, neurological, or musculoskeletal conditions, active vestibular disorders, diagnosed hearing problems, resting blood pressure above 180/100 mmHg, resting heart rate above 120 bpm, or a BMI of 35 or above will be excluded. This young adult population was specifically selected to eliminate age-related confounders

You may qualify if:

• Aged between 18 and 35,
• Able to walk unaided (without the use of a walking aid),
• Participants who agree to take part in the study on a voluntary basis and sign the informed consent form

You may not qualify if:

• A history of myocardial infarction or unstable angina within the last month,
• Acute illness or pain during the test that would prevent walking,
• A lower limb injury or surgery within the last 3 months,
• Resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg,
• Resting heart rate exceeding 120 beats per minute,
• Those with cardiovascular or pulmonary conditions that may limit exercise,
• Those with neurological conditions (balance disorders, stroke, epilepsy, etc.),
• Those with musculoskeletal problems (lower limb fracture, severe arthritis, acute injury, etc.),
• Those with an acute infection, fever or severe fatigue that could prevent walking during the test,
• Those with a body mass index of 35 or above (obesity),
• Those with a history of active vertigo, Meniere's disease or vestibular system disorders,
• Participants with a diagnosed hearing problem

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (14)

• Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.

  PMID: 31689414 RESULT

• Igusa T, Kobayashi T, Uchida H, Tsuchiya K, Akiba T, Sema S, Kaneko S, Yoshita T, Nagai S, Tanaka Y, Kikuchi S, Hirao K. Effect of gait training using rhythmic auditory stimulation on gait speed in older adults admitted to convalescent rehabilitation wards: A study protocol for a pilot randomized controlled clinical trial. Contemp Clin Trials Commun. 2023 Apr 1;33:101125. doi: 10.1016/j.conctc.2023.101125. eCollection 2023 Jun.

  PMID: 37091510 RESULT

• Harrison EC, Grossen S, Tueth LE, Haussler AM, Rawson KS, Campbell MC, Earhart GM. Neural mechanisms underlying synchronization of movement to musical cues in Parkinson disease and aging. Front Neurosci. 2025 Mar 11;19:1550802. doi: 10.3389/fnins.2025.1550802. eCollection 2025.

  PMID: 40134419 RESULT

• Ghai S, Ghai I, Effenberg AO. Effect of Rhythmic Auditory Cueing on Aging Gait: A Systematic Review and Meta-Analysis. Aging Dis. 2018 Oct 1;9(5):901-923. doi: 10.14336/AD.2017.1031. eCollection 2018 Oct.

  PMID: 30271666 RESULT

• Gao X, Cao H, Ming D, Qi H, Wang X, Wang X, Chen R, Zhou P. Analysis of EEG activity in response to binaural beats with different frequencies. Int J Psychophysiol. 2014 Dec;94(3):399-406. doi: 10.1016/j.ijpsycho.2014.10.010. Epub 2014 Oct 31.

  PMID: 25448376 RESULT

• Fleg JL, Strait J. Age-associated changes in cardiovascular structure and function: a fertile milieu for future disease. Heart Fail Rev. 2012 Sep;17(4-5):545-54. doi: 10.1007/s10741-011-9270-2.

  PMID: 21809160 RESULT

• Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.

  PMID: 9817683 RESULT

• Deboeck G, Niset G, Vachiery JL, Moraine JJ, Naeije R. Physiological response to the six-minute walk test in pulmonary arterial hypertension. Eur Respir J. 2005 Oct;26(4):667-72. doi: 10.1183/09031936.05.00031505.

  PMID: 16204599 RESULT

• Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.

  PMID: 10536127 RESULT

• Chen B, Wong C, Dzebley R, Stone JM. Effect of Binaural Beats on Affective Symptoms and Performance on the Digit Span Test. Cureus. 2025 Oct 9;17(10):e94182. doi: 10.7759/cureus.94182. eCollection 2025 Oct.

  PMID: 41216069 RESULT

• Chase CJ, Aguiar EJ, Moore CC, Chipkin SR, Staudenmayer J, Tudor-Locke C, Ducharme SW. Cadence (steps/min) as an indicator of the walk-to-run transition. Hum Mov Sci. 2023 Aug;90:103117. doi: 10.1016/j.humov.2023.103117. Epub 2023 Jun 17.

  PMID: 37336086 RESULT

• Chaieb L, Wilpert EC, Reber TP, Fell J. Auditory beat stimulation and its effects on cognition and mood States. Front Psychiatry. 2015 May 12;6:70. doi: 10.3389/fpsyt.2015.00070. eCollection 2015.

  PMID: 26029120 RESULT

• Braun Janzen T, Koshimori Y, Richard NM, Thaut MH. Rhythm and Music-Based Interventions in Motor Rehabilitation: Current Evidence and Future Perspectives. Front Hum Neurosci. 2022 Jan 17;15:789467. doi: 10.3389/fnhum.2021.789467. eCollection 2021.

  PMID: 35111007 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

Central Study Contacts

Karya Polat, PhD

CONTACT

+90(506)4564649; karia.polat@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

TU (1)