UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063112 |
|---|---|
| Receipt number | R000072236 |
| Scientific Title | Effects of acute exercise combined with virtual reality on psychological and physiological responses in middle-aged adults |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/30 11:15:20 |
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Basic information
Public title
Effects of acute exercise using virtual reality on psychological and physiological functions
Acronym
VR Exercise Study
Scientific Title
Effects of acute exercise combined with virtual reality on psychological and physiological responses in middle-aged adults
Scientific Title:Acronym
VR Exercise Study in Middle-Aged Adults
Region
| Japan |
Condition
Condition
Healthy middle-aged adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Mood state assessed using the MCL-S.2, heart rate variability (HRV), and salivary alpha-amylase activity. Each outcome is assessed before 20 minutes of cycling exercise and after a 5-minute resting period following exercise, and pre-to-post changes are evaluated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
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
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
200
Research contact person
Name of lead principal investigator
| 1st name | KEITA |
| Middle name | |
| Last name | AIHARA |
Organization
Kyorin University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
181-8612
Address
5-4-1 Shimorenjaku, Mitaka, Tokyo, Japan
TEL
0422478000
aihara-k@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | KEITA |
| Middle name | |
| Last name | AIHARA |
Organization
Kyorin University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
181-8612
Address
5-4-1 Shimorenjaku, Mitaka, Tokyo, Japan
TEL
0422478000
Homepage URL
aihara-k@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Keita Aihara
Funding Source
Organization
kyorin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Faculty of Health Sciences, Kyorin University
Address
5-4-1 Shimorenjaku, Mitaka, Tokyo 181-8612, Japan
Tel
0422-47-8000
kyorinri@ksot.kyorin-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 | 09 | Month | 30 | Day |
Related information
URL releasing protocol
Not publicly available
Publication of results
Unpublished
Result
URL related to results and publications
Not publicly available
Number of participants that the trial has enrolled
16
Results
Sixteen participants completed the study. A significant condition-by-time interaction was observed for lnRMSSD, which decreased after exercise in the control condition but showed a small increase in the VR condition. HF norm, LF/HF, salivary alpha-amylase activity, and MCL-S.2 also showed different pre-to-post changes between conditions. No significant between-condition difference was observed in ratings of perceived exertion.
Results date posted
| 2026 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixteen healthy middle-aged adults (10 men and 6 women) participated in the study. Mean age was 47.4 +/- 7.3 years (range, 40-64 years), height was 165.4 +/- 9.2 cm, body weight was 62.5 +/- 10.8 kg, BMI was 22.8 +/- 2.9 kg/m2, and resting blood pressure was 118.8 +/- 8.9/74.1 +/- 5.1 mmHg.
Participant flow
All 16 participants were randomized, with eight allocated to the Control-to-VR sequence and eight to the VR-to-Control sequence. Each participant completed both conditions with a 1-week washout period between sessions. There were no dropouts or missing outcome data, and all 16 participants were included in the analysis.
Adverse events
No adverse events were observed. All 16 participants completed both experimental conditions.
Outcome measures
The primary outcome was lnRMSSD, an index of heart rate variability. Secondary physiological outcomes were HF norm and natural log-transformed salivary alpha-amylase activity (lnsAA). Exploratory outcomes included pleasantness, relaxation, and anxiety assessed using the MCL-S.2, and rating of perceived exertion assessed using the Borg scale.
Plan to share IPD
There is no plan to share individual participant data.
IPD sharing Plan description
Individual participant data will not be shared.
Progress
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 |
Date of closure to data entry
| 2024 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2024 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 30 | Day |
Last modified on
| 2026 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072236
