[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634497":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":35,"locations":41,"responsibleParty":53,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":70,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Hasan Kalyoncu University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Metronome",null,"They will complete the 6-minute walk test whilst listening to a metronome.",[13],"Other: Metronome",{"label":15,"type":10,"description":16,"interventionNames":17},"Binaural beats","They will complete the 6-minute walk test whilst listening to binaural beats.",[18],"Other: Bineural Beats",{"label":20,"type":10,"description":21,"interventionNames":22},"Control","They will complete the 6-minute walk test without any additional auditory conditions.",[23],"Other: Control",[25,28,32],{"type":6,"name":9,"description":26,"armGroupLabels":27,"otherNames":10},"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).\n\nIn 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).",[9],{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":10},"Bineural Beats","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",[15],{"type":6,"name":20,"description":33,"armGroupLabels":34,"otherNames":10},"The 6-minute walk test will be completed without any auditory cues.",[20],[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Karya Polat, PhD","CONTACT","+90(506)4564649","karia.polat@gmail.com",[42],{"facility":5,"status":10,"city":43,"state":10,"zip":10,"country":44,"countryCode":10,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Gaziantep","Turkey (Türkiye)",{"type":46,"coordinates":47},"Point",[48,49],37.3825,37.05944,{"lat":49,"lon":48},[52],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Karya POLAT","Assistant Professor","100634497","the-effect-of-different-acoustic-conditions-on-6-minute-walk-test-performance-and-recovery-100634497",false,"NCT07540455","The Effect of Different Acoustic Conditions on 6-Minute Walk Test Performance and Recovery","An Investigation of the Effect of Different Auditory Conditions on 6-Minute Walk Performance and Recovery in Healthy Young Adults: A Randomised Cross-Over Study","Inclusion Criteria:\n\n* Aged between 18 and 35,\n* Able to walk unaided (without the use of a walking aid),\n* Participants who agree to take part in the study on a voluntary basis and sign the informed consent form\n\nExclusion Criteria:\n\n* A history of myocardial infarction or unstable angina within the last month,\n* Acute illness or pain during the test that would prevent walking,\n* A lower limb injury or surgery within the last 3 months,\n* Resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>100 mmHg,\n* Resting heart rate exceeding 120 beats per minute,\n* Those with cardiovascular or pulmonary conditions that may limit exercise,\n* Those with neurological conditions (balance disorders, stroke, epilepsy, etc.),\n* Those with musculoskeletal problems (lower limb fracture, severe arthritis, acute injury, etc.),\n* Those with an acute infection, fever or severe fatigue that could prevent walking during the test,\n* Those with a body mass index of 35 or above (obesity),\n* Those with a history of active vertigo, Meniere's disease or vestibular system disorders,\n* Participants with a diagnosed hearing problem","ALL","18 Years","35 Years",{"count":68,"type":69},40,"ESTIMATED","1 Day","OBSERVATIONAL","Study Design: Randomized Cross-Over Study\n\nObjective:\n\nThis 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.\n\nBackground:\n\nAuditory-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.\n\nParticipants:\n\nHealthy 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.\n\nRandomization:\n\nAll 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.\n\nInterventions:\n\nMetronome Condition: Each participant's natural walking cadence will be measured, and the metronome tempo will be set at 110% of this baseline value.\n\nBinaural 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.\n\nControl Condition: No auditory stimulus will be applied.\n\nThe 6MWT will be conducted in all conditions along a 30-meter flat corridor in accordance with ATS\u002FERS standards.\n\nMeasurement Time Points: Pre-test, immediately post-test, and at the 1st, 3rd, and 5th minutes of the recovery period.\n\nOutcome Measures:\n\nPrimary: Total distance covered during 6MWT (meters), walking cadence (steps\u002Fmin) Secondary: Heart rate, blood pressure, peripheral oxygen saturation (SpO₂), perceived dyspnea, general fatigue, and quadriceps femoris muscle fatigue assessed via the Modified Borg Scale\n\nStatistical Analysis:\n\nOne-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\\\u003C0.05.\n\nStudy Duration: April - June 2026 (3 months)",[74,75,76],"Recovery","Fatigue Recovery","Healhty",[78,79,80,81],"6 minutes walk test","metronome","binaural","recovery","NOT_YET_RECRUITING","2026-04-14",{"date":85,"type":86},"2026-04-20","ACTUAL",{"date":88,"type":69},"2026-04-15",{"date":90,"type":69},"2026-07-01",{"name":5,"class":6},1]