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Clinical Trials/NCT05326529
NCT05326529
Completed
Not Applicable

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.

University of Chester1 site in 1 country57 target enrollmentJuly 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
University of Chester
Enrollment
57
Locations
1
Primary Endpoint
Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 7, 2022
End Date
February 28, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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

  • 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)

Outcomes

Primary Outcomes

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

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

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.

Secondary Outcomes

  • 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))
  • 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))
  • 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 Sites (1)

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