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Completed

NCT Number: NCT05492526

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

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

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Key information

Conditions

Cardiac Rehabilitation Angina Pectoris Behavior Cardiovascular Diseases Chest Pain Heart Diseases Heart Failure Infarction Ischemia Motor Activity Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool University Hospital NHS Foundation Trust

Liverpool, L78xp, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Individuals using a pacemaker or other internal medical device.
  • Unable to access a computer or tablet with internet access to view the online platform.
  • Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor.
  • Unwillingness to take part.

Treatment and study plan

Ki Monitor without feedback

Device

Physical activity Monitor - No feedback

Ki monitor with contextualised data feedback

Device

Physical activity monitor and feedback

Primary outcomes

  1. Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor

    Time frame: 6 - 8 weeks

    Objective measurement using Ki monitor.

Secondary outcomes

  1. Exercise test result.

    Time frame: 6-8 weeks

    Incremental shuttle walk test or 6 minute walking test, as appropriate

  2. Total calories burned

    Time frame: 6-8 weeks

    Objectively measured using the Ki monitor

  3. Completion of cardiac rehabilitation programme

    Time frame: 6-8 weeks

    Number of participants completed full cardiac rehabilitation programme.

Other outcomes

  1. Quality of life measured using the Dartmouth Coop

    Time frame: 6-8 weeks

    Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.

  2. Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS)

    Time frame: 6-8 weeks

    Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.

  3. Body mass index measured using height and weight and combined to report in kg/m2

    Time frame: 6-8 weeks

    Measured at the beginning and end of Cardiac rehabilitation programme

  4. Blood pressure measured and reported in mmHg

    Time frame: 6- 8 weeks

    Measured before and after exercise tests at the beginning and end of the cardiac rehabilitation programme

  5. Blood Glucose measured and reported in mmol/L

    Time frame: 6-8 weeks

    Measured at the beginning and end of Cardiac rehabilitation programme where appropriate

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Collaborators

  • KiActiv

Registry information

Official study 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.

Acronym: KiCS1

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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