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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05492526
Other study ID # 4807
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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