Comparison of Traditional, Web-based or a Combined Cardiac Rehabilitation Programme

NCT ID: NCT05326529

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-02-28

Brief Summary

The study explores the different modes of Cardiac Rehabilitation delivery including the use of a web-based programme. Cardiac Rehabilitation provides a structured, comprehensive programme, proven to reduce cardiovascular mortality and improve overall Quality of Life. However, as uptake remains relatively low with only 50% attending, exploring the benefits of offering a menu of programme options may allow greater patient choice and accessibility, meeting individual needs.

This study aims to compare how effective Cardiac Rehabilitation Programmes are on improving cardiovascular patients physical and mental wellbeing using a web-based compared with traditional cardiac rehab programmes in the hospital or through a combination of both.

Detailed Description

This 8-week study, aims to compare quality of life (QOL), hospital anxiety and depression scores (HADs) and physical activity outcomes in web-based Cardiac Rehabilitation (CR), web-based CR combined with traditional CR (TCR) and TCR in patients with coronary heart disease (CHD).

The Web-based option will include the use of the MyHeart application.

Participants eligible for the study will include low-moderate cardiovascular patients (heart attack, stents or heart surgery) within 3-6 weeks post discharge. Participants will be involved in hospital or virtual exercise and educational sessions with the support of CR specialists. Primary outcomes will be measured through questionnaires and an incremental treadmill walking test.

To our knowledge, this would be the first study to compare all three groups, as combined CR (web-based alongside traditional CR) has not yet been evaluated. Additionally, the investigators currently work within the CR setting at Burton Hospital, and this study will be conducted within our current Hospital CR service. The outcomes will be applicable and relevant to future clinical practice.

As the UK's 50% uptake to CR remains poor, falling below the 85% national uptake recommendations, a CR menu-based approach, offering hospital or home-based programmes is recommended to encourage uptake, improve QOL and clinical outcomes.

Furthermore, as COVID-19 has enforced a web-based CR approach, further research to explore uptake, physical and psychological outcomes to benefit cardiovascular patients is paramount for current and future CR delivery.

This study will explore a menu of options recommended for CR.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Traditional Cardiac Rehabilitation (Hospital based programme)

Traditional Cardiac Rehabilitation will involve 8 hospital-based exercise sessions, and one virtual education day over 8 weeks, supervised by CR health care professionals.

Group Type: ACTIVE_COMPARATOR

Hospital Based Cardiac Rehabilitation Exercise Classes

Intervention Type: OTHER

Participants will attend 8 Hospital based CR exercise sessions. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Traditional combined with Web-based Cardiac Rehabilitation

Traditional combined with Web-based Cardiac Rehabilitation. Patients will attend 8 hospital-based exercise sessions and one virtual education day over 8-weeks with access to additional web-based (MyHeart app) exercise and educational information.

Group Type: EXPERIMENTAL

Hospital Based Cardiac Rehabilitation Exercise Classes

Intervention Type: OTHER

Participants will attend 8 Hospital based CR exercise sessions. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Web-based Cardiac Rehabilitation Exercise Sessions

Intervention Type: OTHER

Participants will complete 8 weeks of Web-based CR exercise sessions using the MyHeart app. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Web-based Cardiac Rehabilitation

Web-based Cardiac Rehabilitation, using MyHeart app introduced during a pre-CR assessment, will follow an 8-week individualised self-managed platform, allowing contact with the CR health professionals via app messages only (no direct contact for web-based CR).

Group Type: EXPERIMENTAL

Web-based Cardiac Rehabilitation Exercise Sessions

Intervention Type: OTHER

Participants will complete 8 weeks of Web-based CR exercise sessions using the MyHeart app. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Interventions

Hospital Based Cardiac Rehabilitation Exercise Classes

Participants will attend 8 Hospital based CR exercise sessions. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Intervention Type: OTHER

Web-based Cardiac Rehabilitation Exercise Sessions

Participants will complete 8 weeks of Web-based CR exercise sessions using the MyHeart app. QOL and Hospital anxiety and Depression scores through questionnaires and incremental Shuttle Walk tests will be carried out pre and post intervention.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Low-moderate risk patients (low-mod Ejection Fraction (EF) (>40%), including clinically stable Myocardial Infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafts (CABG) patients.
• Acute patients, in-hospital patients (phase 3 rehab) to reflect true clinical representation.
• Combination of male and female, as previous studies are predominately male.
• Low-moderate Anxiety and depression scores (<11)
• Achieve Level 4 (180metres, 5.1METs) on the Incremental Shuttle Walking Test
• Internet and device access.

Exclusion Criteria

• <40% EF
• High risk Heart Failure patients
• Co-morbidities preventing exercise
• No internet access
• Unstable angina
• Language barrier (English only, due to app)
• Clinically depressed anxiety or depression scores (>11)
• Incremental Shuttle Walk Test <Level 4 (180metres, 5.1METs)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Chester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Morris

Role: STUDY_DIRECTOR

University of Chester

Locations

University of Derby and Burton NHS Foundation Trust

Burton-on-Trent, Staffordshire, United Kingdom

Countries

United Kingdom

References

Brough C, Boyce S, Houchen-Wolloff L, Sewell L, Singh S. Evaluating the interactive web-based program, activate your heart, for cardiac rehabilitation patients: a pilot study. J Med Internet Res. 2014 Oct 29;16(10):e242. doi: 10.2196/jmir.3027.

Reference Type: BACKGROUND

PMID: 25359204 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

290193

Identifier Type: -

Identifier Source: org_study_id