The Effect of Different Acoustic Conditions on 6-Minute Walk Test Performance and Recovery
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-35
SponsorHasan Kalyoncu University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial 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
Trial design
Design model
Case-crossover
Time perspective
Cross-sectional
Treatments tested in this trial
Metronome
Other interventionA 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).
Bineural Beats
Other interventionBinaural 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
Control
Other interventionThe 6-minute walk test will be completed without any auditory cues.
Treatment groups
40 Participants
are divided into 3 treatment groupsGroup A: Metronome1 intervention
Group B: Binaural beats1 intervention
Group C: Control1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
24-48-hour period2
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).
Time frame
24-48-hour periodSecondary outcomes
1
Heart rate
Measurements will be taken from participants before the test, at the end of the test, and at 1, 3 and 5 minutes into the recovery period.
Time frame
24-48-hour period2
Peripheral Oxygen Saturation
To monitor arterial oxygenation during exercise and any potential exertion-related desaturation, a finger-type pulse oximeter (Surginatal, Lk47, China) will be used to measure oxygen saturation in conjunction with heart rate. Measurements will be taken from participants before the test, at the end of the test, and at 1, 3 and 5 minutes into recovery.
Time frame
24-48-hour period3
Blood Pressure
To monitor participants' cardiovascular stress response and haemodynamic recovery levels, systolic and diastolic blood pressure measurements will be taken in a seated position at five specified time points using a standard sphygmomanometer (Omron, HEM-7143-E, Netherlands). Measurements will be taken from participants before the test, at the end of the test, and at 1, 3 and 5 minutes into recovery.
Time frame
24-48-hour period4
Dyspnea
Participants will be asked to rate the severity of their shortness of breath on a scale of 6 (none) to 20 (maximum) before the test, at the end of the test, and at 1, 3 and 5 minutes into recovery. Measurements will be taken from participants before the test, at the end of the test, and at 1, 3 and 5 minutes into recovery.
Time frame
24-48-hour periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: