Autonomic Nervous System Imbalance, Patient Adherence, Physical Fitness, Quality of Life
Conditions
Keywords
Exercise tolerance, Heart rate variability, Baroreflex sensitivity
Brief summary
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
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.
Interventions
BEHAVIORALCurrent guidelines rehabilitation
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.
BEHAVIORALMobile device guided rehabilitation
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.
Sponsors
Business Finland
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Six months (baseline and 6 months) | Change in maximal load during exercise stress test (metabolic equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability | Six months (baseline and 6 months) | Change in 24 h SDNN (ms) |
| Change in very low frequency (VLF) of heart rate variability | Six months (baseline and 6 months) | Change in 24 h VLF (ms\^2) |
| Change in low frequency (LF) of heart rate variability | Six months (baseline and 6 months) | Change in 24 h LF (ms\^2) |
| Adherence to exercise rehabilitation | Weekly from baseline to six months | Realized training in relation to prescribed training over six months |
| Change in fractal scaling exponent of heart rate variability | Six months (baseline and 6 months) | Change in 24 h Fractal scaling exponent (a.u.) |
| Change in baroreflex sensitivity | Six months (baseline and 6 months) | Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg) |
| Change in quality of life | Six months (baseline and 6 months) | Change in quality of life measured by 15-D questionaire |
| Change in high frequency (HF) of heart rate variability | Six months (baseline and 6 months) | Change in 24 h HF (ms\^2) |
Countries
Finland
Outcome results
None listed