The Use of Contextualised Body Data in Cardiac Rehabilitation (CR)

Not Applicable

Completed

• Conditions: Cardiac Rehabilitation
• Interventions: Device: Ki Monitor without feedback; Device: Ki monitor with contextualised data feedback

• Registration Number: NCT05492526
• Lead Sponsor: Liverpool University Hospitals NHS Foundation Trust

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.

Study Timeline

• Study Start: 2021-05-07
• Status Verified: 2022-07
• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Primary Completion: 2022-11-11
• Study Completion: 2023-05-23
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

All patients referred to the cardiac rehab programme will be invited to take part in the study.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual Cardiac Rehabilitation	Ki Monitor without feedback	Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period.
Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback	Ki monitor with contextualised data feedback	Patient receives usual care and also wears Ki monitor and receives contextualised data feedback

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Exercise test result.	6-8 weeks	Incremental shuttle walk test or 6 minute walking test, as appropriate

Trial Locations

Locations (1)

Liverpool University Hospital NHS Foundation Trust; 🇬🇧 Liverpool, United Kingdom