Open Heart SurgeryNCT05149235
Gaming Technology and Cardiac Rehabilitation
A study testing early mobilization group and physio adventure in people with Open Heart Surgery, run by Bahria University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Heart Surgery
- What is being tested?
- early mobilization group and physio adventure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2022to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Open Heart Surgery
- Being tested
- early mobilization group, physio adventure, placebo
- Keywords
- Cardiac rehabilitation, autonomic regulation of heart, physical activity, gaming technology, cycle ergometer
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early mobilization groupOther
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).
physio adventureDevice
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.
placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| early mobilization group | Active comparator | this group will perform early mobilization exercises using a cycle ergometer. Receives: Other: early mobilization group |
| game tech group | Experimental | this group will use physio adventure device instead of a cycle ergometer Receives: Device: physio adventure |
| placebo group | Placebo comparator | this group is placebo control and will receive routine respiratory physiotherapy Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in autonomic modulation of heart
autonomic modulation of heart will be assessed by measuring heart rate variability
Measured: heart rate variability will be recorded on day of admission, 1st post-operative day and 4th post operative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Open Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyyada Tahniat Ali, Bahria University
- Investigators
- Seyyada T Ali, Principal investigator, bahria university medical and dental collegemuhammad i tariq, Study director, Riphah International Universityurooj fatima, Study chair, bahria university medical and dental college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149235
- Sponsor's protocol ID
- FRC-BUMDC 23/2021
- Status last verified
- Aug 2025
- First submitted
- 2 Nov 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao Z. Fight fire with fire? Promoting physical activity and health through active video games. J Sport Health Sci. 2017 Mar;6(1):1-3. doi: 10.1016/j.jshs.2016.11.009. Epub 2016 Nov 24. No abstract available.
PubMed 30356540Baranowski T. Pokemon Go, go, go, gone? Games Health J. 2016 Oct;5(5):293-294. doi: 10.1089/g4h.2016.01055.tbp. Epub 2016 Aug 15. No abstract available.
PubMed 27525347European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.
PubMed 20643803Gama Lordello GG, Goncalves Gama GG, Lago Rosier G, Viana PADC, Correia LC, Fonteles Ritt LE. Effects of cycle ergometer use in early mobilization following cardiac surgery: a randomized controlled trial. Clin Rehabil. 2020 Apr;34(4):450-459. doi: 10.1177/0269215520901763. Epub 2020 Jan 29.
PubMed 31994405Cacau Lde A, Oliveira GU, Maynard LG, Araujo Filho AA, Silva WM Jr, Cerqueria Neto ML, Antoniolli AR, Santana-Filho VJ. The use of the virtual reality as intervention tool in the postoperative of cardiac surgery. Rev Bras Cir Cardiovasc. 2013 Jun;28(2):281-9. doi: 10.5935/1678-9741.20130039.
PubMed 23939326Kulur AB, Haleagrahara N, Adhikary P, Jeganathan PS. Effect of diaphragmatic breathing on heart rate variability in ischemic heart disease with diabetes. Arq Bras Cardiol. 2009 Jun;92(6):423-9, 440-7, 457-63. doi: 10.1590/s0066-782x2009000600008. English, Multiple languages.
PubMed 19629309Karapolat H, Engin C, Eroglu M, Yagdi T, Zoghi M, Nalbantgil S, Durmaz B, Kirazli Y, Ozbaran M. Efficacy of the cardiac rehabilitation program in patients with end-stage heart failure, heart transplant patients, and left ventricular assist device recipients. Transplant Proc. 2013 Nov;45(9):3381-5. doi: 10.1016/j.transproceed.2013.06.009.
PubMed 24182820Oliveira NL, Ribeiro F, Alves AJ, Teixeira M, Miranda F, Oliveira J. Heart rate variability in myocardial infarction patients: effects of exercise training. Rev Port Cardiol. 2013 Sep;32(9):687-700. doi: 10.1016/j.repc.2013.02.010. Epub 2013 Aug 30.
PubMed 23993292Pasco D, Roure C, Kermarrec G, Pope Z, Gao Z. The effects of a bike active video game on players' physical activity and motivation. J Sport Health Sci. 2017 Mar;6(1):25-32. doi: 10.1016/j.jshs.2016.11.007. Epub 2016 Nov 24.
PubMed 30356595Ribeiro BC, Poca JJGD, Rocha AMC, Cunha CNSD, Cunha KDC, Falcao LFM, Torres DDC, Rocha LSO, Rocha RSB. Different physiotherapy protocols after coronary artery bypass graft surgery: A randomized controlled trial. Physiother Res Int. 2021 Jan;26(1):e1882. doi: 10.1002/pri.1882. Epub 2020 Oct 25.
PubMed 33103326
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infusion of Gaming Technology With Cardiac Rehabilitation on Autonomic Modulation of Heart: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05149235
- Acronym / sponsor ID
- FRC-BUMDC 23/2021
- Conditions
- Open Heart Surgery
- Keywords
- Cardiac rehabilitation, autonomic regulation of heart, physical activity, gaming technology, cycle ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Bahria UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early mobilization group | Active comparator | Other: early mobilization groupthis group will perform early mobilization exercises using a cycle ergometer. |
| game tech group | Experimental | Device: physio adventurethis group will use physio adventure device instead of a cycle ergometer |
| placebo group | Placebo comparator | Other: placebothis group is placebo control and will receive routine respiratory physiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early mobilization groupParticipants 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). | Other | early mobilization group |
| physio adventureThe 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. | Device | game tech group |
| placeboParticipants 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. | Other | placebo group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 30356540Gao Z. Fight fire with fire? Promoting physical activity and health through active video games. J Sport Health Sci. 2017 Mar;6(1):1-3. doi: 10.1016/j.jshs.2016.11.009. Epub 2016 Nov 24. No abstract available.
- Background: PubMed 27525347Baranowski T. Pokemon Go, go, go, gone? Games Health J. 2016 Oct;5(5):293-294. doi: 10.1089/g4h.2016.01055.tbp. Epub 2016 Aug 15. No abstract available.
- Results publication: PubMed 20643803European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines; EACPR; Corra U, Piepoli MF, Carre F, Heuschmann P, Hoffmann U, Verschuren M, Halcox J; Document Reviewers; Giannuzzi P, Saner H, Wood D, Piepoli MF, Corra U, Benzer W, Bjarnason-Wehrens B, Dendale P, Gaita D, McGee H, Mendes M, Niebauer J, Zwisler AD, Schmid JP. Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation. Eur Heart J. 2010 Aug;31(16):1967-74. doi: 10.1093/eurheartj/ehq236. Epub 2010 Jul 19.
- Results publication: PubMed 31994405Gama Lordello GG, Goncalves Gama GG, Lago Rosier G, Viana PADC, Correia LC, Fonteles Ritt LE. Effects of cycle ergometer use in early mobilization following cardiac surgery: a randomized controlled trial. Clin Rehabil. 2020 Apr;34(4):450-459. doi: 10.1177/0269215520901763. Epub 2020 Jan 29.
- Results publication: PubMed 23939326Cacau Lde A, Oliveira GU, Maynard LG, Araujo Filho AA, Silva WM Jr, Cerqueria Neto ML, Antoniolli AR, Santana-Filho VJ. The use of the virtual reality as intervention tool in the postoperative of cardiac surgery. Rev Bras Cir Cardiovasc. 2013 Jun;28(2):281-9. doi: 10.5935/1678-9741.20130039.
- Results publication: PubMed 19629309Kulur AB, Haleagrahara N, Adhikary P, Jeganathan PS. Effect of diaphragmatic breathing on heart rate variability in ischemic heart disease with diabetes. Arq Bras Cardiol. 2009 Jun;92(6):423-9, 440-7, 457-63. doi: 10.1590/s0066-782x2009000600008. English, Multiple languages.
- Results publication: PubMed 24182820Karapolat H, Engin C, Eroglu M, Yagdi T, Zoghi M, Nalbantgil S, Durmaz B, Kirazli Y, Ozbaran M. Efficacy of the cardiac rehabilitation program in patients with end-stage heart failure, heart transplant patients, and left ventricular assist device recipients. Transplant Proc. 2013 Nov;45(9):3381-5. doi: 10.1016/j.transproceed.2013.06.009.
- Results publication: PubMed 23993292Oliveira NL, Ribeiro F, Alves AJ, Teixeira M, Miranda F, Oliveira J. Heart rate variability in myocardial infarction patients: effects of exercise training. Rev Port Cardiol. 2013 Sep;32(9):687-700. doi: 10.1016/j.repc.2013.02.010. Epub 2013 Aug 30.
- Results publication: PubMed 30356595Pasco D, Roure C, Kermarrec G, Pope Z, Gao Z. The effects of a bike active video game on players' physical activity and motivation. J Sport Health Sci. 2017 Mar;6(1):25-32. doi: 10.1016/j.jshs.2016.11.007. Epub 2016 Nov 24.
- Results publication: PubMed 33103326Ribeiro BC, Poca JJGD, Rocha AMC, Cunha CNSD, Cunha KDC, Falcao LFM, Torres DDC, Rocha LSO, Rocha RSB. Different physiotherapy protocols after coronary artery bypass graft surgery: A randomized controlled trial. Physiother Res Int. 2021 Jan;26(1):e1882. doi: 10.1002/pri.1882. Epub 2020 Oct 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyyada T Ali principal investigator
bahria university medical and dental college
muhammad i tariq study director
Riphah International University
urooj fatima study chair
bahria university medical and dental college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early mobilization group and physio adventure in people with Open Heart Surgery, run by Bahria University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149235, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.