Clinical trial NCT05326529: Comparison of Traditional, Web-based or a Combined Cardiac Rehabilitation Programme
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Cardiac Rehabilitation
Web-based Cardiac Rehabilitation
Lead sponsor: University of Chester
Sponsor class: OTHER
Collaborators: name: University Hospitals of Derby and Burton NHS Foundation Trust
First posted: 2022-04-13
Enrollment: 57
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Three way comparison study.

* Traditional Cardiac Rehabilitation
* Traditional Cardiac Rehabilitation combined with Web-based Cardiac Rehabilitation
* Web-based Cardiac Rehabilitation
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention.
timeFrame: The Walk Test will be completed pre and post intervention (8 weeks apart)
Secondary outcomes:
measure: Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention
timeFrame: Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
measure: Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention.
timeFrame: Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
measure: Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention
timeFrame: The Walk Test will be completed pre and post intervention (8 weeks apart)
Other outcomes:
Locations:
city: Burton Upon Trent
country: United Kingdom
facility: University of Derby and Burton NHS Foundation Trust
state: Staffordshire
Study officials:
affiliation: University of Chester
name: Mike Morris
role: STUDY_DIRECTOR
References:
citation: 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.