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

Cardiovascular Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326529
• Other study ID #: 290193
• Status: Completed
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2023
• Source: University of Chester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	University of Derby and Burton NHS Foundation Trust	Burton Upon Trent	Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Chester	University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy Expenditure	An Incremental Shuttle Walk test will be performed to determine the Metabolic equivalent achieved. Metabolic Equivalent (1 MET) is defined as the amount of energy required to serve the body's energy needs.	The Walk Test will be completed pre and post intervention (8 weeks apart)
Secondary	Psychological outcome - Hospital Anxiety and Depression Score	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.	Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
Secondary	Psychological outcome - Dartmouth Coop Questionnaire	This will be evaluated through participants completing 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. Total score gives a profile of health status.	Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
Secondary	Heart Rate	An Incremental Shuttle Walk test will be performed to evaluate functional capacity and determine what percentage of predicted heart rate the participant has achieved. Heart Rate max will be calculated using the Karvonen Formula	The Walk Test will be completed pre and post intervention (8 weeks apart)