Cardiovascular Diseases
Conditions
Keywords
Cardiac Rehabilitation, Web-based Cardiac Rehabilitation
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.
Interventions
OTHERHospital 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.
OTHERWeb-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.
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
University of Chester
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three way comparison study. * Traditional Cardiac Rehabilitation * Traditional Cardiac Rehabilitation combined with Web-based Cardiac Rehabilitation * Web-based Cardiac Rehabilitation
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment started 7/7/22 - ended 28/2/23 Hospital based programme - Queens hospital Burton, UK - Cardiac Rehabilitation Department
Participants by arm
| Arm | Count |
|---|---|
| Traditional Cardiac Rehabilitation (Hospital Based Programme) Traditional Cardiac Rehabilitation will involve 8 hospital-based exercise sessions, and one virtual education day over 8 weeks, supervised by CR health care professionals.
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. | 19 |
| Traditional Combined With Web-based Cardiac Rehabilitation Traditional combined with Web-based Cardiac Rehabilitation. Patients will attend 8 hospital-based exercise sessions and one virtual education day over 8-weeks with access to additional web-based (MyHeart app) exercise and educational information.
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. | 19 |
| Web-based Cardiac Rehabilitation Web-based Cardiac Rehabilitation, using MyHeart app introduced during a pre-CR assessment, will follow an 8-week individualised self-managed platform, allowing contact with the CR health professionals via app messages only (no direct contact for web-based CR).
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. | 19 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Traditional Combined With Web-based Cardiac Rehabilitation | Web-based Cardiac Rehabilitation | Total | Traditional Cardiac Rehabilitation (Hospital Based Programme) |
|---|---|---|---|---|
| Age, Customized Age 50- 70 years | 19 participants | 19 participants | 57 participants | 19 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 19 participants | 19 participants | 57 participants | 19 participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 46 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 | 0 / 19 |
Outcome results
Primary
Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention.
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.
Time frame: The Walk Test will be completed pre and post intervention (8 weeks apart)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Pre intervention | 5.9 score on a scale |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Post Intervention | 7.4 score on a scale |
| Traditional Combined With Web-based Cardiac Rehabilitation | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Post Intervention | 7.3 score on a scale |
| Traditional Combined With Web-based Cardiac Rehabilitation | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Pre intervention | 5.8 score on a scale |
| Web-based Cardiac Rehabilitation | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Pre intervention | 5.6 score on a scale |
| Web-based Cardiac Rehabilitation | Change From Baseline Energy Expenditure (Measured in METs Using the BACPR Conversion Chart) and After 8 Weeks of Intervention. | Post Intervention | 6.5 score on a scale |
Secondary
Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention
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.
Time frame: The Walk Test will be completed pre and post intervention (8 weeks apart)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Post Intervention | 10.2 score on a scale |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Pre Intervention | 11.3 score on a scale |
| Traditional Combined With Web-based Cardiac Rehabilitation | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Pre Intervention | 11.3 score on a scale |
| Traditional Combined With Web-based Cardiac Rehabilitation | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Post Intervention | 10.2 score on a scale |
| Web-based Cardiac Rehabilitation | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Pre Intervention | 12.2 score on a scale |
| Web-based Cardiac Rehabilitation | Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention | Post Intervention | 10.9 score on a scale |
Secondary
Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention
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.
Time frame: Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Depression Score) | 3.16 score on a scale | Standard Deviation 2.47 |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Anxiety Score) | 4.95 score on a scale | Standard Deviation 3.1 |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Depression Score) | 4.53 score on a scale | Standard Deviation 3.58 |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Anxiety Score) | 3.68 score on a scale | Standard Deviation 2.45 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Depression Score) | 2.44 score on a scale | Standard Deviation 2.09 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Anxiety Score) | 4.00 score on a scale | Standard Deviation 3.77 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Anxiety Score) | 4.56 score on a scale | Standard Deviation 3.05 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Depression Score) | 3.28 score on a scale | Standard Deviation 2.42 |
| Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Anxiety Score) | 4.53 score on a scale | Standard Deviation 2.98 |
| Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Anxiety Score) | 5.65 score on a scale | Standard Deviation 3.25 |
| Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Pre Intervention (Depression Score) | 4.59 score on a scale | Standard Deviation 3.22 |
| Web-based Cardiac Rehabilitation | Psychological Outcome - Hospital Anxiety and Depression Score Pre and Post Intervention | Post Intervention (Depression Score) | 3.94 score on a scale | Standard Deviation 3.03 |
Secondary
Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention.
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.
Time frame: Questionnaires will be given to the patient to complete pre and post intervention. (8 weeks apart)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Post Intervention | 16.4 score on a scale | Standard Deviation 3.57 |
| Traditional Cardiac Rehabilitation (Hospital Based Programme) | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Pre Intervention | 21.9 score on a scale | Standard Deviation 5.63 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Post Intervention | 15.7 score on a scale | Standard Deviation 2.63 |
| Traditional Combined With Web-based Cardiac Rehabilitation | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Pre Intervention | 20.1 score on a scale | Standard Deviation 5.01 |
| Web-based Cardiac Rehabilitation | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Post Intervention | 17.41 score on a scale | Standard Deviation 4.5 |
| Web-based Cardiac Rehabilitation | Psychological Status at Baseline (Using the Dartmouth Coop Questionnaire) and After 8 Weeks of Intervention. | Pre Intervention | 21.35 score on a scale | Standard Deviation 5.38 |