Cardiac Rehabilitation
Conditions
Keywords
Cardiac Rehabilitation, Myocardial Infarction, CABG, NSTEMI, STEMI, Angina, Exercise, Physical activity, Heart failure, Digital Health
Brief summary
KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.
Detailed description
Cardiac rehabilitation (CR) after a heart attack has shown to be more effective than any other medication given after such an event. It is a recommended therapy by NICE. However, only 44% of eligible patients attend rehabilitation and only half of these complete the course. Novel ways to increase uptake and compliance are needed. In this study, calorie burn and physical activity data will be collected using a validated, CE marked physical activity monitor, herein referred to as Ki monitor. Data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for CR to empower people to self-care at home using their personal everyday physical activity. This can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. A small pilot study has been carried out to establish wearability of a physical activity monitor in a CR cohort, which has demonstrated a high level of acceptability. We now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing CR, based on the current ACPICR standards for Daily Activity and At-home Training. All patients referred for CR will be invited to take part. These will be randomised to the usual care (UC) group or the contextualised data feedback (CDF) group. Both groups will wear the Ki monitor for eight weeks. The UC group will receive usual care, the CDF group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.
Interventions
DEVICEKi Monitor without feedback
Physical activity Monitor - No feedback
DEVICEKi monitor with contextualised data feedback
Physical activity monitor and feedback
Sponsors
KiActiv
Liverpool University Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Prospective, randomised, open -label study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
All patients referred to the cardiac rehab programme will be invited to take part in the study.
Exclusion criteria
1. Individuals using a pacemaker or other internal medical device. 2. Unable to access a computer or tablet with internet access to view the online platform. 3. Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor. 4. Unwillingness to take part.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor | 6 - 8 weeks | Objective measurement using Ki monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise test result. | 6-8 weeks | Incremental shuttle walk test or 6 minute walking test, as appropriate |
| Total calories burned | 6-8 weeks | Objectively measured using the Ki monitor |
| Completion of cardiac rehabilitation programme | 6-8 weeks | Number of participants completed full cardiac rehabilitation programme. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life measured using the Dartmouth Coop | 6-8 weeks | Participants completed a questionnaire at the start and end of the cardiac rehabilitation program. |
| Blood Glucose measured and reported in mmol/L | 6-8 weeks | Measured at the beginning and end of Cardiac rehabilitation programme where appropriate |
| Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS) | 6-8 weeks | Participants completed a questionnaire at the start and end of the cardiac rehabilitation program. |
| Body mass index measured using height and weight and combined to report in kg/m2 | 6-8 weeks | Measured at the beginning and end of Cardiac rehabilitation programme |
| Blood pressure measured and reported in mmHg | 6- 8 weeks | Measured before and after exercise tests at the beginning and end of the cardiac rehabilitation programme |
Countries
United Kingdom
Outcome results
None listed