NCT06679348

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2024

Completed
Last Updated

December 20, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

November 1, 2024

Last Update Submit

December 18, 2024

Conditions

Keywords

treadmillvirtual realityheart rate variabilityfatigue

Outcome Measures

Primary Outcomes (1)

  • autonomic nervous system and fatigue levels

    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.

    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).

Study Arms (2)

Virtual Reality Walking Exercise

EXPERIMENTAL

Walking in virtual reality combined with treadmill exercise

Other: Treadmill walking exercise using VR

Walking on Treadmill

EXPERIMENTAL

walking on treadmills

Other: walking exercise on treadmill

Interventions

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.

Walking on Treadmill

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.

Virtual Reality Walking Exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Kagıthane, 34413, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asst.prof.

Study Record Dates

First Submitted

November 1, 2024

First Posted

November 7, 2024

Study Start

November 1, 2024

Primary Completion

December 18, 2024

Study Completion

December 18, 2024

Last Updated

December 20, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations