Clinical trial NCT05149235: Gaming Technology and Cardiac Rehabilitation
Official title: Effects of Infusion of Gaming Technology With Cardiac Rehabilitation on Autonomic Modulation of Heart: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Heart Surgery
Keywords: Cardiac rehabilitation
autonomic regulation of heart
physical activity
gaming technology
cycle ergometer
Lead sponsor: Bahria University
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in autonomic modulation of heart
timeFrame: heart rate variability will be recorded on day of admission, 1st post-operative day and 4th post operative day
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Seyyada Tahniat Ali
state: Sindh
Study officials:
affiliation: bahria university medical and dental college
name: Seyyada T Ali
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: muhammad i tariq
role: STUDY_DIRECTOR
affiliation: bahria university medical and dental college
name: urooj fatima
role: STUDY_CHAIR
References:
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