Gaming Technology and Cardiac Rehabilitation

NCT05149235 | Completed DMC

• 1 other identifier: FRC-BUMDC 23/2021
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Heart Surgery

Keywords

Cardiac rehabilitation; autonomic regulation of heart; physical activity; gaming technology; cycle ergometer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

early mobilization group

ACTIVE COMPARATOR

this group will perform early mobilization exercises using a cycle ergometer.

Other: early mobilization group

game tech group

EXPERIMENTAL

this group will use physio adventure device instead of a cycle ergometer

Device: physio adventure

placebo group

PLACEBO COMPARATOR

this group is placebo control and will receive routine respiratory physiotherapy

Other: placebo

Interventions

early mobilization group OTHER

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).

early mobilization group

physio adventure DEVICE

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.

game tech group

placebo OTHER

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.

placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahria University: lead

Study Sites (1)

Seyyada Tahniat Ali

Karachi, Sindh, 75500, Pakistan

Location

Related Publications (10)

• European 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.

  PMID: 20643803 BACKGROUND

• Gama 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.

  PMID: 31994405 BACKGROUND

• Cacau 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.

  PMID: 23939326 BACKGROUND

• Kulur 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.

  PMID: 19629309 BACKGROUND

• Karapolat 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.

  PMID: 24182820 BACKGROUND

• Oliveira 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.

  PMID: 23993292 BACKGROUND

• 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.

  PMID: 30356540 BACKGROUND

• Baranowski 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.

  PMID: 27525347 BACKGROUND

• Pasco 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.

  PMID: 30356595 BACKGROUND

• Ribeiro 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.

  PMID: 33103326 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Seyyada T Ali

  bahria university medical and dental college

  PRINCIPAL INVESTIGATOR

• muhammad i tariq

  Riphah International University

  STUDY DIRECTOR

• urooj fatima

  bahria university medical and dental college

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical instructor

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 8, 2021
• Study Start: March 10, 2022
• Primary Completion: June 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)