NCT07718763

Brief Summary

Digital game addiction is associated with reduced physical activity, increased sedentary behavior, and adverse physical and psychosocial health outcomes in young adults. This study aims to develop and evaluate the effectiveness of a physiological biofeedback-integrated virtual reality (VR)-based exercise intervention for young adults at risk of digital gaming addiction. In this prospective, single-blind, randomized controlled trial, participants will be randomly assigned to either a VR-based aerobic exercise group or a traditional aerobic exercise group. Both groups will participate in supervised exercise sessions twice weekly for 8 weeks. The primary outcome is physical activity level, while secondary outcomes include functional capacity, muscle strength, physiological responses during exercise, digital gaming addiction severity, exercise enjoyment, and intervention usability.

Trial Health

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Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2026

Status
not yet recruiting

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

July 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2027

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 16, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Virtual RealityPhysiological BiofeedbackExerciseDigital Gaming Addiction

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Level

    Physical activity level will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The primary outcome will be the total physical activity score expressed as metabolic equivalent minutes per week (MET-min/week).

    Baseline and Week 8

Secondary Outcomes (10)

  • Functional Capacity

    Baseline and Week 8

  • Shoulder Abductor Muscle Strength

    Baseline and Week 8

  • Knee Extensor Muscle Strength

    Baseline and Week 8

  • Mean Heart Rate During Exercise

    During each exercise session throughout the 8-week intervention

  • Maximum Heart Rate During Exercise

    During each exercise session throughout the 8-week intervention

  • +5 more secondary outcomes

Study Arms (2)

Virtual Reality-Based Aerobic Exercise

EXPERIMENTAL

Participants will receive a supervised virtual reality-based aerobic exercise program integrated with physiological biofeedback twice weekly for 8 weeks.

Behavioral: Virtual Reality-Based Aerobic Exercise

Traditional Aerobic Exercise

ACTIVE COMPARATOR

Participants will receive a supervised traditional aerobic exercise program matched for exercise intensity and duration twice weekly for 8 weeks.

Behavioral: Traditional Aerobic Exercise

Interventions

Participants will perform supervised aerobic exercise in an immersive virtual reality environment twice weekly for 8 weeks. Exercise intensity will be individualized using heart rate-based physiological biofeedback and progressively adjusted according to participants' physiological responses.

Virtual Reality-Based Aerobic Exercise

Participants will perform a supervised structured aerobic exercise program twice weekly for 8 weeks. Exercise intensity will be individualized according to target heart rate and progressively adjusted throughout the intervention.

Traditional Aerobic Exercise

Eligibility Criteria

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

You may qualify if:

  • Young adults within the eligible age range specified in the study protocol.
  • Currently enrolled as a university student.
  • Playing online digital games for at least 2 hours per day.
  • Internet Gaming Disorder Scale-Short Form (IGDS9-SF) score ≥32.
  • Apparently healthy with no diagnosed chronic disease.
  • Able to participate in moderate-intensity aerobic exercise.
  • Willing to provide written informed consent.

You may not qualify if:

  • Presence of cardiovascular, respiratory, neurological, musculoskeletal, or other medical conditions that may interfere with safe participation in exercise.
  • Use of medications that may affect exercise performance or physiological responses.
  • History of injury or surgery within the previous 6 months that may limit physical activity.
  • Contraindications to aerobic exercise or virtual reality use.
  • Inability to complete the study procedures or refusal to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Internet Addiction DisorderMotor Activity

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This is a single-blind study. Outcome assessments will be performed by an assessor who is blinded to group allocation. Due to the nature of the interventions, participants and treating physiotherapists cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: a virtual reality-based aerobic exercise group or a traditional aerobic exercise group. Both groups will receive supervised aerobic exercise twice weekly for 8 weeks. Exercise intensity in the virtual reality group will be individualized using heart rate-based physiological biofeedback.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 22, 2026

Study Start (Estimated)

September 25, 2026

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

September 25, 2027

Last Updated

July 22, 2026

Record last verified: 2026-07