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Completed

NCT Number: NCT05326529

Comparison of 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.

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Key information

Conditions

Cardiovascular Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Derby and Burton NHS Foundation Trust

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention

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

    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.

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

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

    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.

  3. Heart Rate Walking Speed Index at Baseline 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 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.

Sponsors and collaborators

Lead sponsor

University of Chester

Other

Collaborators

  • University Hospitals of Derby and Burton NHS Foundation Trust

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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