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

Cardiac Rehabilitation Clinical Trial

— KiCS1  

Official title:

Using Body Data for the Purpose of Contextualised Feedback to Enable Established Physical Activity Guidelines to be Delivered in a Free- Living Environment as Part of a Comprehensive Cardiac Rehabilitation Programme.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05492526
• Other study ID #: 4807
• Status: Completed
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: July 2022
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 23, 2023
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

Device:
• Ki Monitor without feedback
Physical activity Monitor - No feedback
• Ki monitor with contextualised data feedback
Physical activity monitor and feedback

Locations

Country	Name	City	State
United Kingdom	Liverpool University Hospital NHS Foundation Trust	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust	KiActiv

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life measured using the Dartmouth Coop	Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.	6-8 weeks
Other	Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS)	Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.	6-8 weeks
Other	Body mass index measured using height and weight and combined to report in kg/m2	Measured at the beginning and end of Cardiac rehabilitation programme	6-8 weeks
Other	Blood pressure measured and reported in mmHg	Measured before and after exercise tests at the beginning and end of the cardiac rehabilitation programme	6- 8 weeks
Other	Blood Glucose measured and reported in mmol/L	Measured at the beginning and end of Cardiac rehabilitation programme where appropriate	6-8 weeks
Primary	Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor	Objective measurement using Ki monitor.	6 - 8 weeks
Secondary	Exercise test result.	Incremental shuttle walk test or 6 minute walking test, as appropriate	6-8 weeks
Secondary	Total calories burned	Objectively measured using the Ki monitor	6-8 weeks
Secondary	Completion of cardiac rehabilitation programme	Number of participants completed full cardiac rehabilitation programme.	6-8 weeks