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

NCT05326529 | Completed Results

• 1 other identifier: 290193
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Cardiac Rehabilitation; Web-based Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention.

  An Incremental Shuttle Walk test will be performed to determine the Metabolic equivalent achieved at each level. Metabolic Equivalent (1 MET) is defined as the amount of energy required to serve the body's energy needs. This will range from 1 METs = lowest energy requirement to 10.9 METs highest energy requirement for completing the test. Walking at a slower pace requires a lower level of energy expenditure and is therefore considered a light-intensity activity, walking at a faster pace requires a higher energy expenditure and is therefore considered a higher-intensity activity. The higher the score the better the outcome for the participant as they are able to work at a higher level of exercise and thus an increase functional capacity which equates to a reduction in risk of mortality.

  The Walk Test will be completed pre and post intervention (8 weeks apart)

Secondary Outcomes (3)

• Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention

  Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)

• Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention.

  Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)

• Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention

  The Walk Test will be completed pre and post intervention (8 weeks apart)

Study Arms (3)

Traditional Cardiac Rehabilitation (Hospital based programme)

ACTIVE COMPARATOR

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

Other: Hospital Based Cardiac Rehabilitation Exercise Classes

Traditional combined with Web-based Cardiac Rehabilitation

EXPERIMENTAL

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.

Other: Hospital Based Cardiac Rehabilitation Exercise Classes; Other: Web-based Cardiac Rehabilitation Exercise Sessions

Web-based Cardiac Rehabilitation

EXPERIMENTAL

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).

Other: Web-based Cardiac Rehabilitation Exercise Sessions

Interventions

Hospital Based Cardiac Rehabilitation Exercise Classes 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 Cardiac Rehabilitation (Hospital based programme); Traditional combined with Web-based Cardiac Rehabilitation

Web-based Cardiac Rehabilitation Exercise Sessions 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.

Traditional combined with Web-based Cardiac Rehabilitation; Web-based Cardiac Rehabilitation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<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)

Sponsors & Collaborators

• University of Chester: lead
• University Hospitals of Derby and Burton NHS Foundation Trust: collaborator

Study Sites (1)

University of Derby and Burton NHS Foundation Trust

Burton-on-Trent, Staffordshire, DE13 0RB, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25359204 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Results Point of Contact

• Title: Charlotte Smith
• Organization: University Hospital of Derby and Burton

charlotte.smith79@nhs.net

01283 593150

Study Officials

• Mike Morris

  University of Chester

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: Three way comparison study. * Traditional Cardiac Rehabilitation * Traditional Cardiac Rehabilitation combined with Web-based Cardiac Rehabilitation * Web-based Cardiac Rehabilitation

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 13, 2022
• Study Start: July 7, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)