Home-based Exercise Training in Cardiac Patients

NCT ID: NCT03704025

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-03
• Study Completion Date: 2021-01-05

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Current guidelines rehabilitation

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

Group Type: ACTIVE_COMPARATOR

Current guidelines rehabilitation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Mobile device guided rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Business Finland

OTHER

Sponsor Role: collaborator

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mikko P Tulppo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

University of Oulu

Oulu, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 38343424 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34741536 (View on PubMed)

Other Identifiers

281/2016

Identifier Type: -

Identifier Source: org_study_id