Trial Outcomes & Findings for Comparison of Traditional, Web-based or a Combined Cardiac Rehabilitation Programme (NCT NCT05326529)
NCT ID: NCT05326529
Last Updated: 2024-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
The Walk Test will be completed pre and post intervention (8 weeks apart)
Results posted on
2024-08-28
Participant Flow
Recruitment started 7/7/22 - ended 28/2/23 Hospital based programme - Queens hospital Burton, UK - Cardiac Rehabilitation Department
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
19
|
|
Overall Study
COMPLETED
|
19
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Traditional Cardiac Rehabilitation (Hospital Based Programme)
n=19 Participants
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.
|
Traditional Combined With Web-based Cardiac Rehabilitation
n=19 Participants
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.
|
Web-based Cardiac Rehabilitation
n=19 Participants
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.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Age 50- 70 years
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
57 participants
n=57 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=19 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=19 Participants
|
11 Participants
n=57 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=19 Participants
|
16 Participants
n=19 Participants
|
17 Participants
n=19 Participants
|
46 Participants
n=57 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
19 participants
n=19 Participants
|
57 participants
n=57 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Traditional Cardiac Rehabilitation (Hospital Based Programme)
n=19 Participants
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.
|
Traditional Combined With Web-based Cardiac Rehabilitation
n=18 Participants
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.
|
Web-based Cardiac Rehabilitation
n=17 Participants
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.
|
|---|---|---|---|
|
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
Interval 5.5 to 6.4
|
5.8 score on a scale
Interval 5.4 to 6.2
|
5.6 score on a scale
Interval 5.2 to 6.0
|
|
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
Interval 6.9 to 7.9
|
7.3 score on a scale
Interval 6.9 to 7.7
|
6.5 score on a scale
Interval 6.1 to 7.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Traditional Cardiac Rehabilitation (Hospital Based Programme)
n=19 Participants
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.
|
Traditional Combined With Web-based Cardiac Rehabilitation
n=18 Participants
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.
|
Web-based Cardiac Rehabilitation
n=17 Participants
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.
|
|---|---|---|---|
|
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
|
4.56 score on a scale
Standard Deviation 3.05
|
5.65 score on a scale
Standard Deviation 3.25
|
|
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
|
4.00 score on a scale
Standard Deviation 3.77
|
4.53 score on a scale
Standard Deviation 2.98
|
|
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
|
3.28 score on a scale
Standard Deviation 2.42
|
4.59 score on a scale
Standard Deviation 3.22
|
|
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
|
2.44 score on a scale
Standard Deviation 2.09
|
3.94 score on a scale
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Traditional Cardiac Rehabilitation (Hospital Based Programme)
n=19 Participants
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.
|
Traditional Combined With Web-based Cardiac Rehabilitation
n=18 Participants
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.
|
Web-based Cardiac Rehabilitation
n=17 Participants
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.
|
|---|---|---|---|
|
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
|
20.1 score on a scale
Standard Deviation 5.01
|
21.35 score on a scale
Standard Deviation 5.38
|
|
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
|
15.7 score on a scale
Standard Deviation 2.63
|
17.41 score on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Traditional Cardiac Rehabilitation (Hospital Based Programme)
n=19 Participants
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.
|
Traditional Combined With Web-based Cardiac Rehabilitation
n=18 Participants
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.
|
Web-based Cardiac Rehabilitation
n=17 Participants
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.
|
|---|---|---|---|
|
Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention
Pre Intervention
|
11.3 score on a scale
Interval 10.2 to 12.5
|
11.3 score on a scale
Interval 10.5 to 12.1
|
12.2 score on a scale
Interval 11.1 to 13.3
|
|
Heart Rate Walking Speed Index at Baseline and After 8 Weeks of Intervention
Post Intervention
|
10.2 score on a scale
Interval 9.3 to 11.1
|
10.2 score on a scale
Interval 9.6 to 10.8
|
10.9 score on a scale
Interval 9.8 to 12.2
|
Adverse Events
Traditional Cardiac Rehabilitation (Hospital Based Programme)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Combined With Web-based Cardiac Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Web-based Cardiac Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Charlotte Smith
University Hospital of Derby and Burton
Phone: 01283 593150
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place