UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062301 |
|---|---|
| Receipt number | R000071295 |
| Scientific Title | Psychophysiological effects of a sound environment containing high-frequency components during exercise and recovery |
| Date of disclosure of the study information | 2026/07/22 |
| Last modified on | 2026/07/22 12:05:16 |
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Basic information
Public title
Effects of sound containing high-frequency components on autonomic recovery after exercise
Acronym
HFC-AR Study
Scientific Title
Psychophysiological effects of a sound environment containing high-frequency components during exercise and recovery
Scientific Title:Acronym
HFC-AR Study
Region
| Japan |
Condition
Condition
Autonomic recovery after aerobic exercise
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a sound environment containing high-frequency components above the audible range on autonomic recovery after aerobic exercise in healthy female university students by comparing the recovery trajectories of heart rate variability indices during the 15-minute post-exercise period under three conditions: silence, audible-range sound only, and audible-range sound plus high-frequency components.
Basic objectives2
Others
Basic objectives -Others
Assessment of the physiological effects of the sound environment on autonomic recovery after exercise
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the root mean square of successive differences between normal-to-normal intervals (RMSSD) during the 15-minute recovery period after aerobic exercise relative to the pre-exercise resting value. The recovery period is evaluated in three intervals: 0-5, 5-10, and 10-15 minutes after exercise.
Key secondary outcomes
1. Changes in the PNS index, SD1, NNxx, and pNNxx during the 0-5, 5-10, and 10-15 minute intervals after exercise relative to the pre-exercise resting values.
2. Heart rate before exercise, during the 15-minute aerobic exercise session, and during the 15-minute post-exercise recovery period.
3. Rating of perceived exertion (RPE) during exercise and the post-exercise recovery period.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Allocation sequence: A, B, and C. A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_2
Allocation sequence: A, C, and B.A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_3
Allocation sequence: B, A, and C.A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_4
Allocation sequence: B, C, and A.A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_5
Allocation sequence: C, A, and B.A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_6
Allocation sequence: C, B, and A.A is silence, B is audible-range sound only at 20 kHz or lower, and C is the same audible sound plus high-frequency components above 20 kHz. Each condition is conducted on a separate experimental day, with one condition per day. Each session consists of 5 minutes of pre-exercise rest, 15 minutes of cycle ergometer exercise at 60 rpm and a target intensity of 50 percent based on the Karvonen formula, and 15 minutes of seated recovery. The assigned sound condition is maintained from pre-exercise rest through post-exercise recovery. The washout period continues until the next experimental day.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy female students enrolled at Hokuriku University who have regular exercise habits and can safely perform cycle ergometer exercise. Participants must understand the purpose and procedures of the study and provide written informed consent.
Key exclusion criteria
Participants without regular exercise habits, defined as exercise once per week or less, for less than 1 hour, and at moderate intensity or lower; participants with hearing impairment, heart disease, mental disorders, smoking habits, regular medication use, or sleep disorders.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Goda |
Organization
Hokuriku University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
920-1180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa, Japan
TEL
076-229-1161
a-goda@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Goda |
Organization
Organization: Hokuriku University
Division name
Department of Physical Therapy, Faculty of Health and Medical Sciences
Zip code
920-1180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa, Japan
TEL
076-229-1161
Homepage URL
a-goda@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuriku University Research Ethics Committee
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa 920-1180, Japan
Tel
076-229-6111
syakairenkei@hokuriku-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071295
