Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation

NCT02711631 | Completed

• 1 other identifier: MedBIKE
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Regular exercise in patients who have heart disease is highly beneficial and improves quality of life and survival. Exercise training is considered a core component of cardiac rehabilitation (CR), which is a multicomponent program delivered to patients who have heart disease. However, it is severely underutilized because people simply don't have the time or the resources to travel to a CR centre to attend rehab appointments. The investigators have developed a novel virtual reality (VR) based CR exercise system (MedBike). This system consists of an exercise bike attached to a VR world; it makes exercise engaging and fun. Furthermore, patients can be monitored during exercise remotely over the internet. The investigators intend to perform a pilot randomized controlled trial in which 10 patients are assigned to the MedBike system and 10 to standard CR. The investigators think that the MedBike system will increase exercise program compliance by providing an enjoyable and engaging exercise experience which can be performed in the comfort of one's own home. The investigators think that this will improve fitness (primary endpoint) in these patients. If the investigators demonstrate that home based exercise is feasible, the investigators plan a larger study to prove that it is something that should be broadly implemented in patients with heart disease.

Conditions

Myocardial Infarction

Keywords

coronary angioplasty; cardiac rehabilitation; coronary artery bypass graft

Outcome Measures

Primary Outcomes (2)

• Fitness

  Change in fitness measured at 8 weeks using Bruce protocol treadmill test performance time as a metric.

  8 weeks

• Compliance

  The investigators will be counting the number of sessions performed in both study arms in their 8 weeks of rehab to determine if there is a difference. This will include scheduled and unscheduled sessions through session documentation and patient self-reporting.

  8 weeks

Secondary Outcomes (4)

• Change in resting blood pressure

  8 weeks

• Change in A1c

  8 weeks

• Smoking status

  8 weeks

• Cholesterol (LDL, HDL, Triglycerides)

  8 weeks

Study Arms (2)

Control: Standard therapy

NO INTERVENTION

Participants in this arm of the study will receive standard therapy.

MedBIKE

EXPERIMENTAL

Participants in this arm will be using the new MedBIKE system as their method of rehabilitation.

Behavioral: MedBIKE

Interventions

MedBIKE BEHAVIORAL

MedBIKE is an exercise cardiac rehabilitation system that allows participants to perform clinical cardiac rehabilitation at home or at a local center, instead of having to travel to the hospital. It provides a high level of physiological monitoring to allow patient safety to be continually monitored while exercising.

MedBIKE

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of stable ischemic heart disease
• received a recent uncomplicated coronary angioplasty or coronary artery bypass graft
• participants will be required to have a referral for cardiac rehabilitation.

You may not qualify if:

• a history of heart failure
• a history of cardiac arrhythmia requiring cardioversion
• an implantable cardiac defibrillator
• unable to cycle on a bike

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Jim Pattison Centre for Heart Health, Mazankowski Heart Institute

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (12)

• Thompson PD, Buchner D, Pina IL, Balady GJ, Williams MA, Marcus BH, Berra K, Blair SN, Costa F, Franklin B, Fletcher GF, Gordon NF, Pate RR, Rodriguez BL, Yancey AK, Wenger NK; American Heart Association Council on Clinical Cardiology Subcommittee on Exercise, Rehabilitation, and Prevention; American Heart Association Council on Nutrition, Physical Activity, and Metabolism Subcommittee on Physical Activity. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease: a statement from the Council on Clinical Cardiology (Subcommittee on Exercise, Rehabilitation, and Prevention) and the Council on Nutrition, Physical Activity, and Metabolism (Subcommittee on Physical Activity). Circulation. 2003 Jun 24;107(24):3109-16. doi: 10.1161/01.CIR.0000075572.40158.77. No abstract available.

  PMID: 12821592 BACKGROUND

• Oldridge NB, Guyatt GH, Fischer ME, Rimm AA. Cardiac rehabilitation after myocardial infarction. Combined experience of randomized clinical trials. JAMA. 1988 Aug 19;260(7):945-50.

  PMID: 3398199 BACKGROUND

• Jelinek MV, Thompson DR, Ski C, Bunker S, Vale MJ. 40 years of cardiac rehabilitation and secondary prevention in post-cardiac ischaemic patients. Are we still in the wilderness? Int J Cardiol. 2015 Jan 20;179:153-9. doi: 10.1016/j.ijcard.2014.10.154. Epub 2014 Oct 29.

  PMID: 25464436 BACKGROUND

• Suaya JA, Shepard DS, Normand SL, Ades PA, Prottas J, Stason WB. Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery. Circulation. 2007 Oct 9;116(15):1653-62. doi: 10.1161/CIRCULATIONAHA.107.701466. Epub 2007 Sep 24.

  PMID: 17893274 BACKGROUND

• Bjarnason-Wehrens B, McGee H, Zwisler AD, Piepoli MF, Benzer W, Schmid JP, Dendale P, Pogosova NG, Zdrenghea D, Niebauer J, Mendes M; Cardiac Rehabilitation Section European Association of Cardiovascular Prevention and Rehabilitation. Cardiac rehabilitation in Europe: results from the European Cardiac Rehabilitation Inventory Survey. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):410-8. doi: 10.1097/HJR.0b013e328334f42d.

  PMID: 20300001 BACKGROUND

• Neubeck L, Freedman SB, Clark AM, Briffa T, Bauman A, Redfern J. Participating in cardiac rehabilitation: a systematic review and meta-synthesis of qualitative data. Eur J Prev Cardiol. 2012 Jun;19(3):494-503. doi: 10.1177/1741826711409326.

  PMID: 22779092 BACKGROUND

• Slovinec D'Angelo ME, Pelletier LG, Reid RD, Huta V. The roles of self-efficacy and motivation in the prediction of short- and long-term adherence to exercise among patients with coronary heart disease. Health Psychol. 2014 Nov;33(11):1344-53. doi: 10.1037/hea0000094. Epub 2014 Aug 18.

  PMID: 25133848 BACKGROUND

• Evenson KR, Fleury J. Barriers to outpatient cardiac rehabilitation participation and adherence. J Cardiopulm Rehabil. 2000 Jul-Aug;20(4):241-6. doi: 10.1097/00008483-200007000-00005.

  PMID: 10955265 BACKGROUND

• Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.

  PMID: 22082676 BACKGROUND

• Pollock ML, Bohannon RL, Cooper KH, Ayres JJ, Ward A, White SR, Linnerud AC. A comparative analysis of four protocols for maximal treadmill stress testing. Am Heart J. 1976 Jul;92(1):39-46. doi: 10.1016/s0002-8703(76)80401-2.

  PMID: 961576 BACKGROUND

• Lear SA, Singer J, Banner-Lukaris D, Horvat D, Park JE, Bates J, Ignaszewski A. Randomized trial of a virtual cardiac rehabilitation program delivered at a distance via the Internet. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):952-9. doi: 10.1161/CIRCOUTCOMES.114.001230. Epub 2014 Sep 30. No abstract available.

  PMID: 25271050 BACKGROUND

• Keteyian SJ, Brawner CA, Savage PD, Ehrman JK, Schairer J, Divine G, Aldred H, Ophaug K, Ades PA. Peak aerobic capacity predicts prognosis in patients with coronary heart disease. Am Heart J. 2008 Aug;156(2):292-300. doi: 10.1016/j.ahj.2008.03.017. Epub 2008 May 22.

  PMID: 18657659 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Raj S Padwal, MD MSc

  Division of General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta

  PRINCIPAL INVESTIGATOR

• Paolo Raggi, MD

  Mazankowski Alberta Heart Institute, University of Alberta Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: March 17, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CA (1)