Clinical trial NCT03704025: Home-based Exercise Training in Cardiac Patients
Official title: Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Fitness
Patient Adherence
Quality of Life
Autonomic Nervous System Imbalance
Keywords: Exercise tolerance
Heart rate variability
Baroreflex sensitivity
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Business Finland
First posted: 2018-10-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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.

Primary outcomes:
measure: Change in exercise capacity
timeFrame: Six months (baseline and 6 months)
Secondary outcomes:
measure: Adherence to exercise rehabilitation
timeFrame: Weekly from baseline to six months
measure: Change in the standard deviation of normal to normal intervals (SDNN) of heart rate variability
timeFrame: Six months (baseline and 6 months)
measure: Change in very low frequency (VLF) of heart rate variability
timeFrame: Six months (baseline and 6 months)
measure: Change in low frequency (LF) of heart rate variability
timeFrame: Six months (baseline and 6 months)
measure: Change in high frequency (HF) of heart rate variability
timeFrame: Six months (baseline and 6 months)
measure: Change in fractal scaling exponent of heart rate variability
timeFrame: Six months (baseline and 6 months)
measure: Change in baroreflex sensitivity
timeFrame: Six months (baseline and 6 months)
measure: Change in quality of life
timeFrame: Six months (baseline and 6 months)
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu
Study officials:
affiliation: University of Oulu
name: Mikko P Tulppo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.