Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063112) titled 'Effects of acute exercise using virtual reality on psychological and physiological functions' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kyorin University
Condition:
Condition - Healthy middle-aged adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of acute exercise using virtual reality on psychological and physiological functions in middle-aged adults using subjective mood measures, heart rate variability, and salivary alpha-amylase activity.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants perform 20 min of recumbent cycling without visual presentation. Cadence is maintained at 60 rpm, and exercise intensity is set at 50% of heart rate reserve (HRR) calculated using the Karvonen formula. Heart rate is continuously monitored during exercise, and when it deviates from the target heart rate by more than approximately 5 bpm in either direction, ergometer resistance is adjusted while maintaining a cadence of 60 rpm. A 1-week washout period is provided between the control and VR conditions.
Interventions/Control_2 - Participants perform 20 min of recumbent cycling while wearing a head-mounted display (HMD) and viewing immersive VR content. Cadence is maintained at 60 rpm, and exercise intensity is set at 50% of heart rate reserve (HRR) calculated using the Karvonen formula. Heart rate is continuously monitored during exercise, and when it deviates from the target heart rate by more than approximately 5 bpm in either direction, ergometer resistance is adjusted while maintaining a cadence of 60 rpm. A 360-degree real-world video is presented, with video playback speed linked to pedaling speed.
Eligibility:
Age-lower limit - 40
years-old
Gender - Male and Female
Key inclusion criteria - 1. Healthy adults aged 40 years or older and younger than 65 years
2. Individuals who received sufficient explanation of the study purpose and procedures and provided written informed consent
3. Individuals without a regular exercise habit
Key exclusion criteria - 1. Individuals with a history of orthopedic, respiratory, cardiovascular, or central nervous system disorders
2. Individuals with signs suggestive of dementia or depression
Target Size - 200
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 07 Month 12 Day
Date of IRB - 2024 Year 07 Month 12 Day
Anticipated trial start date - 2024 Year 08 Month 01 Day
Last follow-up date - 2024 Year 10 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072236
Disclaimer: Curated by HT Syndication.