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.
Phase: NA
Conditions: Cardiovascular Diseases
Sponsor: University of Chester

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
 
 
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. 
 
NCT 05326529 
 
12th April 2022 
 

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
Research Study Protocol Flow Chart 
 
 
 
 
 
 
 
Figure 1. Participant and study design flow chart 

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
 
Research Study Protocol Description 
 
Aim and Objectives 
This Study aims to examine the effectiveness of Physical Activity, Quality of Life and 
Hospital Anxiety and Depression outcomes in Cardiovascular patients using an web-
based Cardiac Rehabilitation application compared with a conventional Cardiac 
Rehabilitation programme or a combination of both. 
 
Recruitment 
Low-moderate risk Coronary Heart Disease Patients (n=60) will be recruited from 
Burton Hospitals NHS Foundation Trust, Cardiac Rehabilitation service.  Patients will 
be invited in accordance with the following inclusion and exclusion criteria; 
Inclusion Criteria-  
• Low-moderate risk patients (low-mod Ejection Fraction (>40% EF), including 
clinically stable Myocardial Infarction, Percutaneous Coronary Intervention, 
Coronary Artery Bypass Graft diagnoses. 
• Age group 50-70 years old, male and female populations 
• Acute in-hospital patients in phase 3 of Cardiac Rehabilitation 
• Low-moderate Anxiety and depression scores (<11) 
• Level 4 (180metres, 4.2 cardiac METs) - level 5 (250metres, 4.9 cardiac METs) 
on the Incremental Shuttle Walking Test (ISWT). 
• Internet and device access. 
 
Exclusion Criteria- 
• <40% Ejection Fraction  
• High risk Heart Failure patients (no HFPEF) 
• Co-morbidities preventing exercise or PA 
• 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, 4.2 cardiac METs) 
 

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
 
 
Randomisation-  
We will have 60 blank envelopes all containing a slip stating which study group the 
participant will be assigned to, i.e., each study group will have 20 slips placed in a 
blank envelope.   
Following the phase 2 nurse telephone contact, the nurses will randomly select one 
of the envelopes to assign each individual patient to either the web-based Cardiac 
Rehabilitation (intervention group), web-based Cardiac Rehabilitation combined with 
Traditional Cardiac Rehabilitation (combination group) or Traditional Cardiac 
Rehabilitation (control group).   
The nurses will then add the patient details onto the study group list and store it in a 
confidential place. 
 
Pre Cardiac Rehabilitation Assessment 
Patients will be invited to an initial assessment at Queens Hospital Burton between 
2-6 weeks post cardiac event which will take approximately 60 minutes.  Patients will 
be introduced to their allocated study group and a consent form will be completed.   
The Incremental Shuttle Walk Test will be performed with the use of a heart rate 
monitor and the Quality of Life and Hospital Anxiety and Depression questionnaires 
will be completed by the patient to gain necessary baseline measures.  All medical 
checks as usual care will be completed.  Patients will be given the opportunity to 
confidentially ask any questions or concerns with the Cardiac Rehabilitation Nurse 
and Exercise Instructor.   
If the patient is selected for the web-based programme the initial assessment will 
take approximately 75 minutes to allocate time for the web-based application 
introduction and the patient will be logged onto the programme. 
 
Eight Weeks Intervention 
Intervention Group 
Patients will follow the Web-based Cardiac Rehabilitation, using MyHeart application, 
introduced during a pre-Cardiac Rehabilitation assessment.  This consists of an 8-
week individualised self-managed platform, allowing contact with the Cardiac 

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
Rehabilitation health professionals via app messages only (no direct contact for web-
based Cardiac Rehabilitation).  The application will involve; 
• 8 weeks of unlimited access to the online walking or exercise programmes  
• A minimum frequency of once per week online exercise session  
• A self-perceived effort scale will be used to ensure you are working to the 
appropriate exercise intensity 
• Flexible access to the online education component  
 
Combination Group 
Patients will be offered the Web-based Cardiac Rehabilitation combined with 
Traditional Cardiac Rehabilitation, consisting of; 
• 8 hospital-based exercise sessions lasting 60minutes in duration 
• A self-perceived effort scale will be used to ensure you are working to the 
appropriate exercise intensity 
• One education day delivered, lasting 5 hours in duration via Microsoft Teams, 
consisting of workshops including nutrition, heart health, medications, physical 
activity, stress and relaxation 
• Patients would also have access to the online education 
 
Control Group 
Patients will be assigned to the Traditional Cardiac Rehabilitation involving 8 
hospital-based exercise sessions and one education day over 8-weeks, supervised 
by Cardiac Rehabilitation health care professionals.  This will involve; 
• 8 supervised sessions over an 8 week duration 
• Each exercise session will last 60minutes in duration 
• The exercise involves a 15 minute group-based warm-up, 15-20 minute 
individualised circuit programme followed by a 10minute cool-down 
• A self-perceived effort scale will be used to ensure you are working to the 
appropriate exercise intensity 
• Virtual education sessions are delivered via teams including various topics 
and speakers over a 5 hour period of duration (heart health, stress, relaxation, 
medications, exercise, nutrition) 
 

 
IRAS ID: 290193 
 
 
Reference Number: 17 
Date: 12/04/2022 
Version Number: 2 
 
 
All patients in each group will have access to our clinical support and advice team 
during our usual clinical hours, Monday-Friday 9-5pm.  If the patient was to feel 
unwell outside of these usual hours, we will advise them to contact NHS 111 for 
further support and advice. 
 
Post Cardiac Rehabilitation Assessment 
Following the 8-weeks intervention, the patient will be invited to a final assessment at 
Queens Hospital Burton which will take approximately 60 minutes.  The Incremental 
Shuttle Walk Test will be performed with the use of a heart rate monitor and the 
Quality of Life and Hospital Anxiety and Depressions questionnaires will be 
completed by the patient to gain necessary post measures.  All medical checks as 
usual care will be completed.  Patients will be given the opportunity to ask any final 
questions or discuss concerns with the Cardiac Rehabilitation Nurse and Exercise 
Instructor.   
Please note, we will be monitoring the following pre and post-measures and intend to 
repeat the following measures only twice throughout the study; Quality of Life, 
Anxiety and Depression Scores, Heart Rate and energy levels.  These measures will 
be completed during the initial and final assessments.  All data will be analysed 
confidentially to review the benefits of the different Cardiac Rehabilitation groups in 
association with the University of Chester. 
 
Data Analysis 
All data will be analysed on SPSS 26 over a two week period.  For Quality of Life 
and Hospital Anxiety and Depression outcomes, Kruskal Wallis ANOVA and 
Wilcoxon tests will be conducted.  For Physical Activity outcomes, mixed ANOVA 
and multiple t-tests will be performed to assess between and within group 
differences. 
 
Sponsor Details 
This study is sponsored by the University of Chester, sponsor contact details are 
Marie-Ann O’neil, 01244 511481, m.oneil@chester.ac.uk.