Autonomous Nervous SystemNCT06679348
Exploring Physiological Responses of Virtual Reality Walking Exercise Versus Treadmill Walking in Healthy Individuals
A study testing walking exercise on treadmill and Treadmill walking exercise using VR in people with Autonomous Nervous System and Fatigue, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to systematically compare the physiological responses generated by walking exercises conducted in a VR environment versus those performed on a treadmill, with a specific focus on their impacts on the autonomic nervous system and fatigue levels Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomous Nervous System, Fatigue
- What is being tested?
- walking exercise on treadmill and Treadmill walking exercise using VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 18 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- classified as inactive or minimally active according to the International Physical Activity Questionnaire score
- voluntary consent to participate
- body mass index (BMI) of ≤30 kg/m²
Who cannot join
- presence of visual, auditory, vestibular, or neurological deficits
- a history of inflammatory diseases, surgeries, or cancer
- any cardiopulmonary disorders, including asthma, within the last six months
- major musculoskeletal injuries sustained within the last six months
- function, such as diabetes mellitus or autonomic neuropathy
- current smoking status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kagıthane, 34413
About this study
Official title: Comparison of Physiological Responses of Virtual Reality Walking Exercise Compared to Walking Performed on Treadmills in Healthy Individuals
This study aimed to systematically compare the physiological responses generated by walking exercises conducted in a VR environment versus those performed on a treadmill, with a specific focus on their impacts on the autonomic nervous system and fatigue levels
Read the detailed description
This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. Faculty of health sciences students from İstanbul Atlas University were invited to participate in this study. The inclusion criteria were as follows: aged between 18 and 25 years; classified as inactive or minimally active according to the International Physical Activity Questionnaire score; voluntary consent to participate; and a body mass index (BMI) of ≤30 kg/m².
Participants were excluded from the study if they met any of the following conditions: presence of visual, auditory, vestibular, or neurological deficits; a history of inflammatory diseases, surgeries, or cancer; any cardiopulmonary disorders, including asthma, within the last six months; major musculoskeletal injuries sustained within the last six months; other health issues that could compromise safety during exercise; or conditions known to affect autonomic nervous system (ANS) function, such as diabetes mellitus or autonomic neuropathy or current smoking status or failure to adhere to the experimental procedures of our study.
Our study comprehensively examines the effects of virtual reality (VR) walking exercise and traditional treadmill walking on autonomic nervous system (ANS) and fatigue levels during recovery.
Investigations into the physiological responses elicited by VR exercise interventions underscore a critical gap in our understanding of how VR modalities produce distinct responses compared with conventional exercise forms, particularly treadmill walking.
- Conditions
- Autonomous Nervous System, Fatigue
- Being tested
- walking exercise on treadmill, Treadmill walking exercise using VR
- Keywords
- treadmill, virtual reality, heart rate variability, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walking exercise on treadmillOther
The study included two intervention groups, consisting of participants who met the inclusion criteria and adhered to the experimental procedures. One group will do treadmill walking exercises, while the other will do treadmill walking exercises using virtual reality (VR). Both interventions were conducted in a single session, with each group participating in a 20-minute walking exercise session at a moderate intensity, as identified by other studies.
Treadmill walking exercise using VROther
Walking on the treadmill with the Free Run game on the Nintendo Wii allows users to walk at 5 miles per hour for 20 minutes. The user gets on the Wii Balance Board and starts walking in the virtual environment after running the application. The application detects the user's movements and controls the progress of the virtual character. During this experience, users increase their motivation by encountering various landscapes while tracking their performance and getting information about the calories they spend. This setup provides a fun, game-like atmosphere for a realistic walking experience.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Walking Exercise | Experimental | Walking in virtual reality combined with treadmill exercise Receives: Other: Treadmill walking exercise using VR |
| Walking on Treadmill | Experimental | walking on treadmills Receives: Other: walking exercise on treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomic nervous system and fatigue levels
- Autonomic Nervous System Function Measure: Heart Rate Variability (HRV) via Polar H10 chest strap. Unit of Measure: Milliseconds (ms) for HRV, reflecting autonomic balance. Interpretation: Higher HRV scores typically indicate better autonomic nervous system regulation, suggesting increased vagal tone and resilience to stress.
- Fatigue Levels
Measure: OMNI Scale of Perceived Exertion (OMNI). Unit of Measure: OMNI Scale ranges from 0 (no fatigue) to 10 (maximum fatigue). Interpretation: Higher scores indicate greater perceived exertion and fatigue, while lower scores suggest less perceived exertion.
Measured: Assessments were conducted at four key time points: before the exercise session (T1), immediately after exercise completion (T2), and during the recovery phase at ten minutes post-exercise (T3) and thirty minutes post-exercise (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Nov 2024
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomous Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SOzkan, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679348
- Sponsor's protocol ID
- Autonomous Nervous System
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physiological Responses of Virtual Reality Walking Exercise Compared to Walking Performed on Treadmills in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06679348
- Acronym / sponsor ID
- Autonomous Nervous System
- Conditions
- Autonomous Nervous System, Fatigue
- Keywords
- treadmill, virtual reality, heart rate variability, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to systematically compare the physiological responses generated by walking exercises conducted in a VR environment versus those performed on a treadmill, with a specific focus on their impacts on the autonomic nervous system and fatigue levels
Detailed description
This study was designed as a single-blind, randomized controlled trial. It was conducted in accordance with the Declaration of Helsinki, adhering to ethical principles for medical research involving human participants. Faculty of health sciences students from İstanbul Atlas University were invited to participate in this study. The inclusion criteria were as follows: aged between 18 and 25 years; classified as inactive or minimally active according to the International Physical Activity Questionnaire score; voluntary consent to participate; and a body mass index (BMI) of ≤30 kg/m².
Participants were excluded from the study if they met any of the following conditions: presence of visual, auditory, vestibular, or neurological deficits; a history of inflammatory diseases, surgeries, or cancer; any cardiopulmonary disorders, including asthma, within the last six months; major musculoskeletal injuries sustained within the last six months; other health issues that could compromise safety during exercise; or conditions known to affect autonomic nervous system (ANS) function, such as diabetes mellitus or autonomic neuropathy or current smoking status or failure to adhere to the experimental procedures of our study.
Our study comprehensively examines the effects of virtual reality (VR) walking exercise and traditional treadmill walking on autonomic nervous system (ANS) and fatigue levels during recovery.
Investigations into the physiological responses elicited by VR exercise interventions underscore a critical gap in our understanding of how VR modalities produce distinct responses compared with conventional exercise forms, particularly treadmill walking.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Walking Exercise | Experimental | Other: Treadmill walking exercise using VRWalking in virtual reality combined with treadmill exercise |
| Walking on Treadmill | Experimental | Other: walking exercise on treadmillwalking on treadmills |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- classified as inactive or minimally active according to the International Physical Activity Questionnaire score
- voluntary consent to participate
- body mass index (BMI) of ≤30 kg/m²
Key exclusion criteria (6 listed)
- presence of visual, auditory, vestibular, or neurological deficits
- a history of inflammatory diseases, surgeries, or cancer
- any cardiopulmonary disorders, including asthma, within the last six months
- major musculoskeletal injuries sustained within the last six months
- function, such as diabetes mellitus or autonomic neuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walking exercise on treadmillThe study included two intervention groups, consisting of participants who met the inclusion criteria and adhered to the experimental procedures. One group will do treadmill walking exercises, while the other will do treadmill walking exercises using virtual reality (VR). Both interventions were conducted in a single session, with each group participating in a 20-minute walking exercise session at a moderate intensity, as identified by other studies. | Other | Walking on Treadmill |
| Treadmill walking exercise using VRWalking on the treadmill with the Free Run game on the Nintendo Wii allows users to walk at 5 miles per hour for 20 minutes. The user gets on the Wii Balance Board and starts walking in the virtual environment after running the application. The application detects the user's movements and controls the progress of the virtual character. During this experience, users increase their motivation by encountering various landscapes while tracking their performance and getting information about the calories they spend. This setup provides a fun, game-like atmosphere for a realistic walking experience. | Other | Virtual Reality Walking Exercise |
Primary outcome
autonomic nervous system and fatigue levels
Time frame: Assessments were conducted at four key time points: before the exercise session (T1), immediately after exercise completion (T2), and during the recovery phase at ten minutes post-exercise (T3) and thirty minutes post-exercise (T4).
1. Autonomic Nervous System Function Measure: Heart Rate Variability (HRV) via Polar H10 chest strap. Unit of Measure: Milliseconds (ms) for HRV, reflecting autonomic balance. Interpretation: Higher HRV scores typically indicate better autonomic nervous system regulation, suggesting increased vagal tone and resilience to stress. 2. Fatigue Levels Measure: OMNI Scale of Perceived Exertion (OMNI). Unit of Measure: OMNI Scale ranges from 0 (no fatigue) to 10 (maximum fatigue). Interpretation: Higher scores indicate greater perceived exertion and fatigue, while lower scores suggest less perceived exertion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking exercise on treadmill and Treadmill walking exercise using VR in people with Autonomous Nervous System and Fatigue, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autonomic nervous system and fatigue levels (time frame: Assessments were conducted at four key time points: before the exercise session (T1), immediately after exercise completion (T2), and during the recovery phase at ten minutes post-exercise (T3) and thirty minutes post-exercise (T4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.