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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704025
Other study ID # 281/2016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2018
Est. completion date January 5, 2021

Study information

Verified date January 2022
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 5, 2021
Est. primary completion date January 5, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Current 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.
Mobile 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.

Locations

Country Name City State
Finland University of Oulu Oulu

Sponsors (2)

Lead Sponsor Collaborator
University of Oulu Business Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in exercise capacity Change in maximal load during exercise stress test (metabolic equivalents) Six months (baseline and 6 months)
Secondary Adherence to exercise rehabilitation Realized training in relation to prescribed training over six months Weekly from baseline to six months
Secondary 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)
Secondary Change in very low frequency (VLF) of heart rate variability Change in 24 h VLF (ms^2) Six months (baseline and 6 months)
Secondary Change in low frequency (LF) of heart rate variability Change in 24 h LF (ms^2) Six months (baseline and 6 months)
Secondary Change in high frequency (HF) of heart rate variability Change in 24 h HF (ms^2) Six months (baseline and 6 months)
Secondary Change in fractal scaling exponent of heart rate variability Change in 24 h Fractal scaling exponent (a.u.) Six months (baseline and 6 months)
Secondary Change in baroreflex sensitivity Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg) Six months (baseline and 6 months)
Secondary Change in quality of life Change in quality of life measured by 15-D questionaire Six months (baseline and 6 months)
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