NCT06708364

Brief Summary

To determine effects of VR training on Heart Rate Variability (HRV), Recovery Heart rate (RHR), Rate Pressure Product (RPP) and Rate of Perceived Exertion (RPE) in sedentary Individuals. Sedentary behavior is a significant public health concern associated with various chronic diseases and reduced quality of life. By elucidating the potential of virtual reality training as an innovative approach to promote physical activity and improve cardiovascular health, this research contributes to addressing the growing burden of sedentary lifestyle-related health conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

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

Study Start

First participant enrolled

November 20, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

November 25, 2024

Last Update Submit

May 21, 2025

Conditions

Sedentary Behavior

Keywords

Heart rate variabilityRecovery Heart rateVirtual Reality TrainingSedentary life style

Outcome Measures

Primary Outcomes (4)

  • Heart Rate Variability (HRV)

    From baseline till 2nd, 4th, and 6th weeks measured through wireless ECG device which measures inter-beat (RR) intervals while doing physical activities. In adults , average HRV is 42 milliseconds.

    2 weeks, 4 weeks, 6 weeks

  • Recovery Heart Rate

    From baseline till 2nd, 4th, and 6th weeks measured through pulse oximeter. One-minute HRR for the average person is between 15 to 25 bpm, with a higher number indicating a quicker recovery and a potentially healthier heart.

    2 weeks, 4 weeks, 6 weeks

  • Rate Pressure Product

    Changes from baseline to 2 weeks, 4 weeks and 6 weeks after the intervention, measured through product of heart rate and systolic blood pressure, is a very reliable indicator of myocardial oxygen demand. An RPP above 20,000 mmHg per minute is considered healthy, whereas anything below 16,000 mmHg is considered insufficient.

    2 weeks, 4 weeks, 6 weeks

  • Rating of Perceived Exertion (RPE)

    Changes from baseline to 2 weeks, 4 weeks and 6 weeks after the intervention, measured through Borg RPE scale for measuring an individual's effort and exertion, breathlessness and fatigue during physical work. The RPE scale ranges from 6 to 20, each gradually related to the respondent's perceived exertion level.

    2 weeks, 4 weeks, 6 weeks

Study Arms (2)

Virtual Reality Training

EXPERIMENTAL

Virtual reality training (X-BOX) for 6 weeks

Other: Virtual Reality Training

Cycle Ergometer

ACTIVE COMPARATOR

Aerobic activity on cycle ergometer for 6 weeks

Other: Cycle Ergometer

Interventions

Virtual Reality TrainingOTHER

Virtual reality training (X-BOX). Table tennis * Frequency: 3 day per week * Intensity: Mild to moderate as per Game. Exer-game ( River Rush) * Time: total 30 minute of training with 5 min warm and 5 min cool down. * Type: aerobic exercise

Virtual Reality Training
Cycle ErgometerOTHER

* Frequency: 3 days per week. * Intensity: 40-60% of HRR * Time: total 30 minutes with 5 min warm up and 5 min cool down * Type: aerobic exercise

Cycle Ergometer

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Sedentary Individuals (IPAQ-short version) \< 3.3 METS daily
  • Daily sitting time≤7 hours

You may not qualify if:

  • Decline Consent
  • Known cases of systemic or Cardiovascular Diseases.
  • Obese (Asian BMI) \> 29.9
  • Any contra-indication to exercise/ Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Railway General Hospital

Rawalpindi, Punjab Province, 26054, Pakistan

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mehwish Waseem, MSPT-CPPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

November 20, 2024

Primary Completion

May 1, 2025

Study Completion

May 15, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)