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

To Examine the Effectiveness of Physical Activity, Quality of Life and Hospital Anxiety and Depression Outcomes in Cardiovascular Patients Using Either Traditional, Web-based or a Combined Cardiac Rehabilitation Programme.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Hospital Based Cardiac Rehabilitation Exercise Classes; Other: Web-based Cardiac Rehabilitation Exercise Sessions

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Staffordshire
    • Burton Upon Trent, Staffordshire, United Kingdom, DE13 0RB
      • University of Derby and Burton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Experimental: 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.	Other: 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.; 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.
Experimental: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention	This will be evaluated through participants completing a Hospital Anxiety and Depression questionnaire. Scoring range: 0-7 = normal range, 8-10 = borderline abnormal,11-21 abnormal and treatment is indicated. The questionnaire comprises of 7 questions for Anxiety and 7 for Depression with a total score for each ranging from 1-21. The scores will be reported separately for Anxiety and depression. The higher the score the worse the outcome for the participant as this indicates a higher level of either anxiety or depression.	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.	This will be evaluated through participants completing a questionnaire consisting of questions measuring health status, physical fitness, feelings, daily activities, social activities, change in health status, current overall health perceptions and bodily pain. Each question gives 5 response options, 1= very good, 2= good, 3= Moderate, 4=Bad, 5= Very Bad. Minimum score = 9, maximum score 45. Total score gives a profile of health status i.e, higher total score = poor health status. The scores will be evaluated at baseline and after 8 weeks of intervention. The score should be lower after 8 weeks to a reflect an improvement in overall health status.	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	An Incremental Shuttle Walk test will be performed to evaluate functional capacity and determine what percentage of predicted heart rate the participant has achieved at each level of the walk test. The maximum Heart Rate achieved at the end of the walk test will then be converted to walking speed index (HRWSI). This will be converted using the BACPR HRWSI table which looks at the number of heart beats for every 10 meters walked when completing a standardised walking test. HRWSI is calculated by dividing Heart rate by the walking speed (meters per minute) multiplied by 10 to give heart beats per minute walked. Possible score ranges are 3-90 (heart beats per 10 meters). If heart rate has decreased at any given point of the walking test compared with the baseline test, this represents an increase in aerobic fitness.	The Walk Test will be completed pre and post intervention (8 weeks apart)

Collaborators and Investigators

• Sponsor: University of Chester
• Collaborators: University Hospitals of Derby and Burton NHS Foundation Trust
• Investigators: Study Director: Mike Morris, University of Chester

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 23, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac Rehabilitation; Web-based Cardiac Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 290193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No