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

NCT05492526 | Completed

• 1 other identifier: 4807
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Rehabilitation

Keywords

Cardiac Rehabilitation; Myocardial Infarction; CABG; NSTEMI; STEMI; Angina; Exercise; Physical activity; Heart failure; Digital Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Exercise test result.

  6-8 weeks

• Total calories burned

  6-8 weeks

• Completion of cardiac rehabilitation programme

  6-8 weeks

Other Outcomes (5)

• Quality of life measured using the Dartmouth Coop

  6-8 weeks

• Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS)

  6-8 weeks

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

  6-8 weeks

Study Arms (2)

Usual Cardiac Rehabilitation

OTHER

Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period.

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

Device: Ki monitor with contextualised data feedback

Interventions

Ki Monitor without feedback DEVICE

Physical activity Monitor - No feedback

Usual Cardiac Rehabilitation

Ki monitor with contextualised data feedback DEVICE

Physical activity monitor and feedback

Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead
• KiActiv: collaborator

Study Sites (1)

Liverpool University Hospital NHS Foundation Trust

Liverpool, L78xp, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction; Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction; Angina Pectoris; Motor Activity; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Study Officials

• Micheal Fisher

  Liverpool University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective, randomised, open -label study

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 8, 2022
• Study Start: May 7, 2021
• Primary Completion: November 11, 2022
• Study Completion: May 23, 2023
• Last Updated: August 1, 2023

Record last verified: 2022-07

Locations

GB (1)