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NCT Number: NCT03704025

Home-based Exercise Training in Cardiac Patients

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.

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Key information

Conditions

Physical Fitness Autonomic Nervous System Imbalance Behavior Health Behavior Patient Acceptance of Health Care Patient Adherence Patient Compliance Quality of Life Treatment Adherence and Compliance

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oulu

Oulu, 90014, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Current guidelines rehabilitation

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in exercise capacity

    Time frame: Six months (baseline and 6 months)

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

Secondary outcomes

  1. Adherence to exercise rehabilitation

    Time frame: Weekly from baseline to six months

    Realized training in relation to prescribed training over six months

  2. Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability

    Time frame: Six months (baseline and 6 months)

    Change in 24 h SDNN (ms)

  3. Change in very low frequency (VLF) of heart rate variability

    Time frame: Six months (baseline and 6 months)

    Change in 24 h VLF (ms^2)

  4. Change in low frequency (LF) of heart rate variability

    Time frame: Six months (baseline and 6 months)

    Change in 24 h LF (ms^2)

  5. Change in high frequency (HF) of heart rate variability

    Time frame: Six months (baseline and 6 months)

    Change in 24 h HF (ms^2)

  6. Change in fractal scaling exponent of heart rate variability

    Time frame: Six months (baseline and 6 months)

    Change in 24 h Fractal scaling exponent (a.u.)

  7. Change in baroreflex sensitivity

    Time frame: Six months (baseline and 6 months)

    Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg)

  8. Change in quality of life

    Time frame: Six months (baseline and 6 months)

    Change in quality of life measured by 15-D questionaire

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Business Finland

Registry information

Official study title

Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients

Acronym: VAPA-Oulu

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2018
Registry last updated
Jan 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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