Gaming Technology and Cardiac Rehabilitation

August 22, 2025 updated by: Seyyada Tahniat Ali, Bahria University

Effects of Infusion of Gaming Technology With Cardiac Rehabilitation on Autonomic Modulation of Heart: a Randomized Control Trial

Moderate to vigorous physical activity has been shown to be associated with autonomic regulation of the heart measured with heart rate variability. Cardiac autonomic modulation can be evaluated by heart rate variability. Activity promoting games can be an effective tool to aid rehabilitation in clinical settings. Combining gaming with the ergo-cycle can facilitate improving patients' activity time spent on the cycle.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Physical activity is recognized as a central component of cardiac rehabilitation, improving control of cardiovascular risk factors, reducing the incidence of adverse events, leading to improvements in cardiovascular conditioning and prevention of thromboembolic events. Consequently, it provides greater physical independence and safety for hospital discharge. Coronary artery bypass grafting (CABG) surgery may lead to prolonged bed rest, and immobility, which can result in negative consequences, such as a decrease in functional capacity, decrease in muscle mass and muscle tone, postural hypotension, and changes in autonomic modulation of the heart rate. Cardiac autonomic modulation can be evaluated by heart rate variability (HRV), which involves simple noninvasive measurement of the oscillations in intervals between consecutive heartbeats.

Technology such as video games plays a complicated role in physical inactivity-much like a double-edged sword. To overcome this problem, the newly emerged active video games have been increasingly used to promote physical activity and health among various populations. Augmented reality games are unique because they integrate the physical and virtual worlds into a single interface using mobile devices applications. Investigators present a proof of concept of an endless running game called physio adventure which implements an activity recognition system that detects cycle rotation and its speed. The goal is to replace the traditional rehabilitation devices with innovative gaming technology with a more natural movement-based one, showing the potential of this kind of interaction to create innovative and immersive experiences while promoting physical activity.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Seyyada Tahniat Ali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients submitted to elective cardiac surgery (valvular or coronary bypass surgery by sternotomy)
  • Both male and female
  • a score of 15 on the Glasgow Coma Scale
  • musculoskeletal, and cardiopulmonary conditions suitable for the accomplishment of the proposed activities
  • absence of neurological sequelae and/or neurodegenerative diseases

Exclusion Criteria:

  • Those who had difficulty understanding the activities involved in the study.
  • those with any motor or neurological impairment that would prevent them from using a cycle ergometer.
  • those who discontinued the protocol on the ward for return to the ICU
  • previous cardiac surgeries
  • hemodynamic instability that prevented protocol performance
  • breathing discomfort
  • invasive ventilatory support
  • oxygen saturation below 90% (even with complementary oxygen therapy)
  • coagulation disorders
  • infections in any of the systems
  • nonperformance of the whole protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: early mobilization group
this group will perform early mobilization exercises using a cycle ergometer.
Other: early mobilization group
Participants will perform exercises using only the cycle ergometer and ambulation. In this group, participants will be instructed to turn the pedals continuously, without any weight added to the equipment (only on 1st post-operative day) and training load will be determined by a fatigue level maintenance of 4 or 5 on the modified Borg scale with a maximum HR elevation of 20% on 2nd and 3rd post-operative days. Duration of exercise will be of 10 minutes (five minutes with the upper limbs and five minutes with the lower limbs). For the arm exercises, the individuals will be positioned with the head end of the bed raised to 60° above the horizontal, while ensuring that all the equipment responsible for measuring the patient's vital signs remained connected. For the leg exercises, the head end of the bed will be lowered to a 30° angle to provide better access to the pedals and avoid compensatory hip movements. Ambulation will be performed only on 3rd post-operative day (40 meters).
Experimental: game tech group
this group will use physio adventure device instead of a cycle ergometer
Device: physio adventure
The protocol applied to the experimental group will be the same of that applied to the early mobilization group with the use of smart move instead of cycle ergometer.
Placebo Comparator: placebo group
this group is placebo control and will receive routine respiratory physiotherapy
Other: placebo
Participants allocated to the Control group will perform respiratory physiotherapy (Flow-oriented incentive spirometer (3×15), active exercises for lower and upper limbs, with each movement being repeated 10 times in an open kinetic chain. For the upper limbs, movements of anterior flexion of the shoulder will be performed until achieving maximum range of motion, using diagonal movements starting at the contralateral iliac crest up to the maximum range of anterior flexion of the shoulder associated with supination. For the lower limbs, exercises will consist of straight leg raises, hip and knee flexion-extension exercise and ankle pumps. Sessions will be of 10 minutes duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in autonomic modulation of heart
Time Frame: heart rate variability will be recorded on day of admission, 1st post-operative day and 4th post operative day
autonomic modulation of heart will be assessed by measuring heart rate variability
heart rate variability will be recorded on day of admission, 1st post-operative day and 4th post operative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahria University

Investigators

  • Principal Investigator: Seyyada T Ali, Bahria University Medical and Dental College
  • Study Director: muhammad i tariq, Riphah International University
  • Study Chair: urooj fatima, Bahria University Medical and Dental College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRC-BUMDC 23/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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