Cardiac RehabilitationKiCS1NCT05492526
The Use of Contextualised Body Data in Cardiac Rehabilitation (CR)
A study testing Ki Monitor without feedback and Ki monitor with contextualised data feedback in people with Cardiac Rehabilitation, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Ki Monitor without feedback and Ki monitor with contextualised data feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2021to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients referred to the cardiac rehab programme will be invited to take part in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospital NHS Foundation Trust
Liverpool, L78xp
About this study
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.
KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.
Read the 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Ki Monitor without feedback, Ki monitor with contextualised data feedback
- Keywords
- Cardiac Rehabilitation, Myocardial Infarction, CABG, NSTEMI, STEMI, Angina, Exercise, Physical activity, Heart failure, Digital Health
- Medical subject headings
- Myocardial Infarction, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Angina Pectoris, Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ki Monitor without feedbackDevice
Physical activity Monitor - No feedback
Ki monitor with contextualised data feedbackDevice
Physical activity monitor and feedback
| Study group | Role | What they receive |
|---|---|---|
| Usual Cardiac Rehabilitation | Other | Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period. Receives: Device: Ki Monitor without feedback |
| Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback | Experimental | Patient receives usual care and also wears Ki monitor and receives contextualised data feedback Receives: Device: Ki monitor with contextualised data feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor
Objective measurement using Ki monitor.
Measured: 6 - 8 weeks
Secondary outcomes (3)
Exercise test result.
Incremental shuttle walk test or 6 minute walking test, as appropriate
Measured: 6-8 weeks
Total calories burned
Objectively measured using the Ki monitor
Measured: 6-8 weeks
Completion of cardiac rehabilitation programme
Number of participants completed full cardiac rehabilitation programme.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start7 May 2021
- Primary completion11 Nov 2022
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Prospective, randomised, open -label study
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- KiActiv
- Responsible party
- Sponsor
- Investigators
- Micheal Fisher, Principal investigator, Liverpool University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492526
- Sponsor's protocol ID
- 4807
- Acronym
- KiCS1
- Status last verified
- Jul 2022
- First submitted
- 20 Jul 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05492526
- Acronym / sponsor ID
- KiCS1 / 4807
- Conditions
- Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation, Myocardial Infarction, CABG, NSTEMI, STEMI, Angina, Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- KiActiv
- Study start
- 7 May 2021 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomised, open -label study
| Arm | Type | Receives |
|---|---|---|
| Usual Cardiac Rehabilitation | Other | Device: Ki Monitor without feedbackPatients 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 | Experimental | Device: Ki monitor with contextualised data feedbackPatient receives usual care and also wears Ki monitor and receives contextualised data feedback |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred to the cardiac rehab programme will be invited to take part in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ki Monitor without feedbackPhysical activity Monitor - No feedback | Device | Usual Cardiac Rehabilitation |
| Ki monitor with contextualised data feedbackPhysical activity monitor and feedback | Device | Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback |
Primary outcome
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.
3 secondary outcomes
Exercise test result.
Time frame: 6-8 weeks
Total calories burned
Time frame: 6-8 weeks
Completion of cardiac rehabilitation programme
Time frame: 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Micheal Fisher principal investigator
Liverpool University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ki Monitor without feedback and Ki monitor with contextualised data feedback in people with Cardiac Rehabilitation, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor (time frame: 6 - 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.