Home-based Exercise Training in Cardiac Patients

Quality of Life Clinical Trial

— VAPA-Oulu  

Official title:

Effects of Virtual Physiotherapy on Exercise Training in Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704025
• Other study ID #: 281/2016
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: January 5, 2021

Study information

• Verified date: January 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Nervous System Imbalance
• Patient Adherence
• Physical Fitness
• Quality of Life

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	University of Oulu	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Business Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in exercise capacity	Change in maximal load during exercise stress test (metabolic equivalents)	Six months (baseline and 6 months)
Secondary	Adherence to exercise rehabilitation	Realized training in relation to prescribed training over six months	Weekly from baseline to six months
Secondary	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)
Secondary	Change in very low frequency (VLF) of heart rate variability	Change in 24 h VLF (ms^2)	Six months (baseline and 6 months)
Secondary	Change in low frequency (LF) of heart rate variability	Change in 24 h LF (ms^2)	Six months (baseline and 6 months)
Secondary	Change in high frequency (HF) of heart rate variability	Change in 24 h HF (ms^2)	Six months (baseline and 6 months)
Secondary	Change in fractal scaling exponent of heart rate variability	Change in 24 h Fractal scaling exponent (a.u.)	Six months (baseline and 6 months)
Secondary	Change in baroreflex sensitivity	Change in spontaneous baroreflex sensitivity by cross-spectral method (ms/mmHg)	Six months (baseline and 6 months)
Secondary	Change in quality of life	Change in quality of life measured by 15-D questionaire	Six months (baseline and 6 months)