Clinical trial NCT05492526: The Use of Contextualised Body Data in Cardiac Rehabilitation (CR)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Cardiac Rehabilitation
Myocardial Infarction
CABG
NSTEMI
STEMI
Angina
Exercise
Physical activity
Heart failure
Digital Health
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: KiActiv
First posted: 2022-08-08
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, randomised, open -label study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor
timeFrame: 6 - 8 weeks
Secondary outcomes:
measure: Exercise test result.
timeFrame: 6-8 weeks
measure: Total calories burned
timeFrame: 6-8 weeks
measure: Completion of cardiac rehabilitation programme
timeFrame: 6-8 weeks
Other outcomes:
measure: Quality of life measured using the Dartmouth Coop
timeFrame: 6-8 weeks
measure: Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS)
timeFrame: 6-8 weeks
measure: Body mass index measured using height and weight and combined to report in kg/m2
timeFrame: 6-8 weeks
measure: Blood pressure measured and reported in mmHg
timeFrame: 6- 8 weeks
measure: Blood Glucose measured and reported in mmol/L
timeFrame: 6-8 weeks
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospital NHS Foundation Trust
Study officials:
affiliation: Liverpool University Hospitals NHS Trust
name: Micheal Fisher
role: PRINCIPAL_INVESTIGATOR
References: