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Clinical Trials/NCT03704025
NCT03704025
Completed
Not Applicable

Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients

University of Oulu1 site in 1 country50 target enrollmentJanuary 3, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Fitness
Sponsor
University of Oulu
Enrollment
50
Locations
1
Primary Endpoint
Change in exercise capacity
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2018
End Date
January 5, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • life-expectancy due to other serious disease \< 2 years or any other reason why patient is unable or unwilling to provide written informed consent.

Outcomes

Primary Outcomes

Change in exercise capacity

Time Frame: Six months (baseline and 6 months)

Change in maximal load during exercise stress test (metabolic equivalents)

Secondary Outcomes

  • Adherence to exercise rehabilitation(Weekly from baseline to six months)
  • Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability(Six months (baseline and 6 months))
  • Change in very low frequency (VLF) of heart rate variability(Six months (baseline and 6 months))
  • Change in low frequency (LF) of heart rate variability(Six months (baseline and 6 months))
  • Change in high frequency (HF) of heart rate variability(Six months (baseline and 6 months))
  • Change in fractal scaling exponent of heart rate variability(Six months (baseline and 6 months))
  • Change in baroreflex sensitivity(Six months (baseline and 6 months))
  • Change in quality of life(Six months (baseline and 6 months))

Study Sites (1)

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