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

Effects of Virtual Physiotherapy on 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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Physical Fitness; Autonomic Nervous System Imbalance; Patient Adherence
• Intervention / Treatment: Behavioral: Current guidelines rehabilitation; Behavioral: Mobile device guided rehabilitation

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90014
    • University of Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Current guidelines rehabilitation; Exercise rehabilitation at home according to current guidelines. Training is guided and controlled by diary.	Behavioral: Current guidelines rehabilitation; 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.
EXPERIMENTAL: 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.	Behavioral: Mobile device guided rehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in exercise capacity	Change in maximal load during exercise stress test (metabolic equivalents)	Six months (baseline and 6 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Business Finland
• Investigators: Principal Investigator: Mikko P Tulppo, PhD, University of Oulu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2018
• Primary Completion (ACTUAL): January 5, 2021
• Study Completion (ACTUAL): January 5, 2021

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (ACTUAL): October 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Heart rate variability; Exercise tolerance; Baroreflex sensitivity
• Other Study ID Numbers: 281/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No