Home-based Exercise Training in Cardiac Patients

Not Applicable

Completed

• Conditions: Physical Fitness; Patient Adherence; Quality of Life; Autonomic Nervous System Imbalance
• Interventions: Behavioral: Mobile device guided rehabilitation; Behavioral: Current guidelines rehabilitation

• Registration Number: NCT03704025
• Lead Sponsor: University of Oulu

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.

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Primary Completion: 2021-01-05
• Study Completion: 2021-01-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-05
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile device guided rehabilitation	Mobile device guided rehabilitation	Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by virtual augmented reality glasses or by mobile device.
Current guidelines rehabilitation	Current guidelines rehabilitation	Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary.

Primary Outcome Measures

Name	Time	Method
Change in exercise capacity	Six months (baseline and 6 months)	Change in maximal load during exercise stress test (metabolic equivalents)

Secondary Outcome Measures

Name	Time	Method
Adherence to exercise rehabilitation	Weekly from baseline to six months	Realized training in relation to prescribed training over 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 24 h SDNN (ms)
Change in very low frequency (VLF) of heart rate variability	Six months (baseline and 6 months)	Change in 24 h VLF (ms\^2)
Change in low frequency (LF) of heart rate variability	Six months (baseline and 6 months)	Change in 24 h LF (ms\^2)
Change in high frequency (HF) of heart rate variability	Six months (baseline and 6 months)	Change in 24 h HF (ms\^2)
Change in fractal scaling exponent of heart rate variability	Six months (baseline and 6 months)	Change in 24 h Fractal scaling exponent (a.u.)
Change in baroreflex sensitivity	Six months (baseline and 6 months)	Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg)
Change in quality of life	Six months (baseline and 6 months)	Change in quality of life measured by 15-D questionaire

Trial Locations

Locations (1)

University of Oulu; 🇫🇮 Oulu, Finland