Gaming Technology and Cardiac Rehabilitation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Open Heart Surgery

Intervention / Treatment
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* Other: early mobilization group
* Device: physio adventure
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early mobilization group<br>this group will perform early mobilization exercises using a cycle ergometer. | Other: early mobilization group<br>* 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).<br>|
| Experimental: game tech group<br>this group will use physio adventure device instead of a cycle ergometer | Device: physio adventure<br>* 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.<br>|
| Placebo Comparator: placebo group<br>this group is placebo control and will receive routine respiratory physiotherapy | Other: placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in autonomic modulation of heart | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac rehabilitation, autonomic regulation of heart, physical activity, gaming technology, cycle ergometer