Home-based Exercise Training in Cardiac Patients (VAPA-Oulu)

University of Oulu

Status: Completed

Conditions: Physical Fitness; Autonomic Nervous System Imbalance; Quality of Life; Patient Adherence

Treatments: Behavioral: Mobile device guided rehabilitation; Behavioral: Current guidelines rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03704025

281/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Current guidelines rehabilitation

Active Comparator group

Description:

Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary.

Treatment:

Behavioral: Current guidelines rehabilitation

Mobile device guided rehabilitation

Experimental group

Description:

Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by virtual augmented reality glasses or by mobile device.

Treatment:

Behavioral: Mobile device guided rehabilitation