Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062301) titled 'Effects of sound containing high-frequency components on autonomic recovery after exercise' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hokuriku University
Condition:
Condition - Autonomic recovery after aerobic exercise
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 50
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071295
Disclaimer: Curated by HT Syndication.