Home-based Exercise Training in Cardiac Patients

Study Overview
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Brief Summary
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The investigators hypothesize that exercise training program guided by virtual augmented reality glasses or by video from computer screen used at home will improve motivation into exercise training and results in superior adherence to exercise training compared to current practice. The primary objectives of this research project are to study the effects of exercise training guidance by novel technology on 1) exercise capacity, 2) adherence to exercise training, 3) changes in cardiac autonomic function and 4) quality of life in acute coronary syndrome (ACS) patients.

Detailed Description
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The subjects of the study will be recruited from the consecutive series of patients of men and women admitted to Oulu University Hospital due to an acute coronary syndrome (ACS). The study population will be randomized into control group (n=25) and study group (n=25) matched with age and gender. For all subjects, clinical status including quality of life questionnaire, exercise capacity and autonomic function measurements will be performed at baseline and after exercise training. Exercise training program is six months for both groups according to current guidelines. All the patients will have a detailed and personalized training prescription. Study group will have virtual augmented reality glasses or computer with training video to motivate and control exercise training prescription at home.

Official Title
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Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients

Conditions
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Physical Fitness, Patient Adherence, Quality of Life, Autonomic Nervous System Imbalance

Intervention / Treatment
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* Behavioral: Current guidelines rehabilitation
* Behavioral: Mobile device guided rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent (< 1 month) acute coronary syndrome Exclusion Criteria: New York Heart Association (NYHA) functional classification class IV (heart failure) unstable chest pain (angina pectoris, Canadian Cardiovascular Society grading of angina pectoris class 4) ST-segment elevation myocardial infarction (STEMI) implanted cardioverter defibrillation or pacemaker (or planned) chronic atrial fibrillation musculoskeletal disorder (unable to participate exercise training) participation in competing clinical trial severe peripheral atherosclerosis retinopathy or neuropathy dementia life-expectancy due to other serious disease < 2 years or any other reason why patient is unable or unwilling to provide written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current guidelines rehabilitation<br>Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary. | Behavioral: Current guidelines rehabilitation<br>* Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. All the patients will have a detailed and personalized training diary.<br>|
| Experimental: Mobile device guided rehabilitation<br>Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by virtual augmented reality glasses or by mobile device. | Behavioral: Mobile device guided rehabilitation<br>* Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. Study group will have virtual glasses or mobile device to motivate and control exercise training program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exercise capacity | Change in maximal load during exercise stress test (metabolic equivalents) | Six months (baseline and 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to exercise rehabilitation | Realized training in relation to prescribed training over six months | Weekly from baseline to six months | 
| Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability | Change in 24 h SDNN (ms) | Six months (baseline and 6 months) | 
| Change in very low frequency (VLF) of heart rate variability | Change in 24 h VLF (ms^2) | Six months (baseline and 6 months) | 
| Change in low frequency (LF) of heart rate variability | Change in 24 h LF (ms^2) | Six months (baseline and 6 months) | 
| Change in high frequency (HF) of heart rate variability | Change in 24 h HF (ms^2) | Six months (baseline and 6 months) | 
| Change in fractal scaling exponent of heart rate variability | Change in 24 h Fractal scaling exponent (a.u.) | Six months (baseline and 6 months) | 
| Change in baroreflex sensitivity | Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg) | Six months (baseline and 6 months) | 
| Change in quality of life | Change in quality of life measured by 15-D questionaire | Six months (baseline and 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise tolerance, Heart rate variability, Baroreflex sensitivity