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Gaming Technology and Cardiac Rehabilitation

B

Bahria University

Status

Completed

Conditions

Open Heart Surgery

Treatments

Device: physio adventure
Other: placebo
Other: early mobilization group

Study type

Interventional

Funder types

Other

Identifiers

NCT05149235
FRC-BUMDC 23/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

86 participants in 3 patient groups, including a placebo group

early mobilization group
Active Comparator group
Description:
this group will perform early mobilization exercises using a cycle ergometer.
Treatment:
Other: early mobilization group
game tech group
Experimental group
Description:
this group will use physio adventure device instead of a cycle ergometer
Treatment:
Device: physio adventure
placebo group
Placebo Comparator group
Description:
this group is placebo control and will receive routine respiratory physiotherapy
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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