Clinical trial NCT02711631: Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
Official title: Feasibility and Effectiveness of Remote Virtual Reality-Based Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: coronary angioplasty
cardiac rehabilitation
coronary artery bypass graft
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2016-03-17
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Fitness
timeFrame: 8 weeks
measure: Compliance
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in resting blood pressure
timeFrame: 8 weeks
measure: Change in A1c
timeFrame: 8 weeks
measure: Smoking status
timeFrame: 8 weeks
measure: Cholesterol (LDL, HDL, Triglycerides)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Jim Pattison Centre for Heart Health, Mazankowski Heart Institute
state: Alberta
Study officials:
affiliation: Division of General Internal Medicine, Faculty of Medicine and Dentistry, University of Alberta
name: Raj S Padwal, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Mazankowski Alberta Heart Institute, University of Alberta Hospital
name: Paolo Raggi, MD
role: PRINCIPAL_INVESTIGATOR
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