Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional

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.
    

Detailed description: 
      Background Regular exercise, incorporated as part of a comprehensive cardiac rehabilitation
      (CR) program, improves morbidity and mortality in cardiac patients, especially those with
      elevated risk profiles. It was reported in a review that exercise decreased all-cause
      mortality, cardiac mortality, and non-fatal myocardial infarction by 20 to 25%. Of critical
      importance, CR non-participants exhibit a 30% lower survival rate than those who participate.

      Even though exercise training is considered a core component of cardiac rehabilitation it is
      severely underutilized. The majority of adult patients do not participate in exercise
      rehabilitation following cardiac events or cardiac surgery; of those eligible, the completion
      rates are 15% to 30%. Factors associated with poor compliance include greater distance from
      the hospital, need for transportation (e.g. and parking fees), lack of self motivation, poor
      social support, low self-esteem, fear of safety and lack of enjoyment. In order to overcome
      these barriers, researchers and clinicians have been turning toward eHealth solutions to
      decentralize the CR process, increase accessibility, and potentially increase the comfort and
      enjoyment derived from exercise. This approach aligns closely with the American Heart
      Association's recommendation that Internet-based techniques be used to improve the CR
      experience for both patients and healthcare providers.

      The Advanced Man Machine Interface Laboratory (AMMI), University of Alberta has developed a
      novel virtual reality (VR) enhanced exercise system (MedBIKE) which provides an engaging and
      enjoyable exercise experience while allowing CR patients to exercise in the comfort of their
      own home. The system consists of a mountain bike mounted on a wirelessly controlled
      resistance machine fed directly into a VR console.

      This VR console allows for a heightened exercise experience for the patient by allowing them
      to cycle through a virtual landscape. While exercising, the patients are monitored remotely
      in real-time by a CR clinician using wireless biometric sensors (electrocardiogram, blood
      pressure, and pulse oximetry) and a bidirectional audio-video Internet connection. The
      investigators believe that by enhancing the exercise experience, eliminating distance and
      transportation issues, and providing ongoing support from key healthcare providers, patient
      compliance with the CR exercise program will improve. The MedBIKE has not been tested in a
      clinical trial.

      Objective and Hypothesis:

      To perform a randomized pilot feasibility study to assess the:

        1. Feasibility of having CR patients perform home-based exercise with MedBIKE

        2. Effectiveness of the MedBIKE system to improve fitness (as measured by exercise
           tolerance testing using the Bruce protocol). Since this is a feasibility trial, it will
           not be fully powered but the investigators will gain preliminary information for a
           sample size calculation (for a larger trial)

        3. Effectiveness of the MedBIKE system to improve patient compliance to CR.

      The investigators hypothesize that home-based CR using the MedBIKE system is feasible and
      will effectively improve fitness and compliance (more frequent exercise sessions and a
      greater number of total hours). The latter endpoints may not reach statistical significance
      but the investigators plan a larger funding application to Canadian Institute for Health
      Research for a properly powered study based upon sample size calculations provided by this
      pilot randomized control trial.

      Methods Adults (age 18y or older) who have had a recent cardiac event, angioplasty or cardiac
      surgery (within 2 weeks) and who have been referred for CR at the Jim Pattison Centre for
      Heart Health (JPCHH) will be enrolled in this pilot randomised controlled trial. Consecutive,
      consenting subjects will be randomised 1:1 (computer based randomisation through an
      independent clinical trials centre to ensure allocation concealment independent of the study
      team) to the MedBike system or standard rehabilitation in the JPCHH.

      Subjects:

      Twenty participants (10 intervention and 10 control) will be enrolled. To avoid enrolling
      higher risk subjects that require in-person CR supervision, the investigators will exclude
      subjects with a history of heart failure, cardiomyopathy, severe valvular disease or rhythm
      disturbances requiring cardioversion. Patients with defibrillators and those unable to
      consent, speak English, comprehend study procedures, cycle on a stationary bike, perform a
      treadmill test, or access the internet from home will be excluded.

      Controls (Standard CR) The standard cardiac rehab program is 8 weeks in duration, with
      patients exercising under supervision once per week in the JPCHH. Each session will consist
      of 30 minutes of cardiorespiratory exercise at a moderate intensity (60 to 80% of predicted
      heart rate max or maximum effort achieved during an exercise tolerance test) and a 5-minute
      warm-up and cool down period. Participants will be encouraged to supplement the JPCHH program
      with an additional optional 2-3 activity sessions per week to be performed in the home or a
      commercial exercise facility, in accordance with the standard therapy protocol of the JCPHH.
      No upper limit of training sessions will be set.

      Intervention Subjects in the intervention arm will complete the same exercise prescription
      assigned to the JPCHH patients (i.e.one session will be scheduled per week for 8 weeks as
      described above). MedBIKE patients will also be encouraged to use the MedBIKE an additional
      2-3x/week (these are optional training sessions). No upper limit of training sessions will be
      set. Scheduled training sessions will be monitored remotely in real-time by a cardiac
      rehabilitation clinician from the JPCHH via a bidirectional audio-video feed. Biometric
      information (electrocardiogram, blood pressure, pulse oximetry) will be collected in real
      time. Monitoring will occur from a clinic room in the JPCHH. Biometric information from the
      training sessions will be stored on a secure server located within the Faculty of Medicine
      and Dentistry, University of Alberta. A secure, encrypted, HIPAA compliant data transmission
      profile will be utilized for patient data transmission, reception and storage.

      Additional Care Other elements of protocolized CR including multidisciplinary care will
      remain unaltered in both groups. This includes a supervised treadmill test performed upon
      admission to, and discharge from, the JPCHH using the Bruce protocol.

      Endpoints:

        1. Fitness: Measured at baseline and 8wk in the JPCHH using the Bruce protocol exercise
           tolerance test. The total time exercised will be determined. For the primary endpoint,
           similar to prior studies, the investigators will calculate the proportion of patients
           achieving an increase in 1 min from baseline to 8 weeks and compare this proportion
           between groups. A 1 min increase corresponds to a 1 to 1.5 metabolic equivalent increase
           on the Bruce protocol; this translates to a projected 12% to 50% reduction in mortality.

        2. Compliance: by comparing the number of scheduled supervised sessions attended (either in
           the JPCHH [controls] or remotely supervised [intervention]), the self-reported total
           number exercise sessions participated in, and the cumulative number of hours exercised
           by each subject. These latter two endpoints will thus include information collected from
           optional exercise sessions.

        3. Change in cardiovascular risk factors from baseline to 8wk: blood pressure (BP), A1c,
           smoking status, lipids.

      Data Collection and Analysis:

      Baseline data collection will include age, sex, smoking status, past medical history
      including cardiovascular risk factors and disease, height, weight, waist circumference, BP,
      A1c, fasting lipid profile, resting heart rate, and Bruce protocol treadmill time. Follow-up
      data collection (at 8 weeks) will include updated medical events, weight, waist
      circumference, BP, A1c, fasting lipids, resting heart rate, follow-up treadmill time,
      self-reported total number of exercise sessions and hours exercised. Continuous variables
      will be summarized as means ± standard deviations (SD) and dichotomous variables as counts
      and proportions. Continuous outcomes will be compared between study arms using logistic
      regression adjusting for age, sex and unbalanced baseline characteristics (including for the
      primary endpoint). Linear regression will be used for dichotomous outcomes and Poisson
      regression for counts.

      Sample Size:

      The sample size is low, but this is a feasibility trial. Only one CR session per week will be
      supervised; optional CR sessions will be ascertained through self-report, which is prone to
      bias. However, to mitigate this, fitness will be assessed through an objective treadmill
      test.
    

Intervention name(s): MedBIKE
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: coronary angioplasty; cardiac rehabilitation; coronary artery bypass graft