Home-based Exercise Training in Cardiac Patients

NCT03704025 | Completed

• 1 other identifier: 281/2016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Exercise tolerance; Heart rate variability; Baroreflex sensitivity

Outcome Measures

Primary Outcomes (1)

• Change in exercise capacity

  Change in maximal load during exercise stress test (metabolic equivalents)

  Six months (baseline and 6 months)

Secondary Outcomes (8)

• Adherence to exercise rehabilitation

  Weekly from baseline to 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 very low frequency (VLF) of heart rate variability

  Six months (baseline and 6 months)

• Change in low frequency (LF) of heart rate variability

  Six months (baseline and 6 months)

• Change in high frequency (HF) of heart rate variability

  Six months (baseline and 6 months)

Study Arms (2)

Current guidelines rehabilitation

ACTIVE COMPARATOR

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

Behavioral: Current guidelines rehabilitation

Mobile device guided rehabilitation

EXPERIMENTAL

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

Interventions

Current guidelines rehabilitation BEHAVIORAL

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.

Current guidelines rehabilitation

Mobile device guided rehabilitation BEHAVIORAL

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.

Mobile device guided rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recent (\< 1 month) acute coronary syndrome

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oulu: lead
• Business Finland: collaborator

Study Sites (1)

University of Oulu

Oulu, 90014, Finland

Location

Related Publications (2)

• Saarikoski EO, Roiha ETM, Kiviniemi AM, Cerdan-De-Las-Heras J, Perkiomaki J, Kaikkonen KS, Tulppo MP. Adherence to exercise after an acute coronary syndrome: a 6-month randomized controlled trial. Front Physiol. 2024 Jan 26;15:1319907. doi: 10.3389/fphys.2024.1319907. eCollection 2024.

  PMID: 38343424 DERIVED

• 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.

  PMID: 34741536 DERIVED

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mikko P Tulppo, PhD

  University of Oulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: October 12, 2018
• Study Start: January 3, 2018
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)