NCT05292287

Brief Summary

The investigators would like to test the feasibility of a remotely prescribed and monitored exercise program in people with coronary heart disease, using a wearable activity device and text message support, compared to usual care after completing cardiac rehabilitation. One group will use a Polar Ignite watch to guide them through exercise sessions at home and will receive text message feedback. The other group will be asked to continue their routine as usual. Assessments of both groups will happen after the completion of cardiac rehabilitation and at three follow-up time points of three, six, and twelve months. The aim of these treatments is to see if the investigators can help people to maintain their exercise adherence and coronary heart disease risk factor management after completing cardiac rehabilitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 28, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1.9 years

First QC Date

December 16, 2021

Last Update Submit

August 19, 2024

Conditions

Coronary Heart Disease

Keywords

Coronary Heart DiseaseExercise MaintenanceCardiac RehabilitationHome-based ExerciseWearable Activity Monitor

Outcome Measures

Primary Outcomes (10)

  • Intervention feasibility assessed via recruitment rate.

    The investigators will complete enrolment logs to record the number of people who enrol in the study.

    Will be evaluated after the 12-month follow up assessment

  • Intervention feasibility assessed via number of screened patients.

    The investigators will complete screening logs to record the number of eligible participants.

    Will be evaluated after the 12-month follow up assessment

  • Intervention feasibility assessed via number of patients randomised.

    The investigators will complete randomisation logs to record the number of participants randomised to both groups.

    Will be evaluated after the 12-month follow up assessment

  • Intervention feasibility assessed via number of patients retained in the study.

    The investigators will assess the number of participants who withdraw or stay within the study.

    Will be evaluated after the 12-month follow up assessment

  • Adherence to the prescribed exercise sessions.

    The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of prescribed exercise sessions completed will be assessed.

    Will be evaluated after the 12-month follow up assessment.

  • Adherence to the prescribed exercise sessions' intensity.

    The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of exercise time completed at the correct intensity will be assessed.

    Will be evaluated after the 12-month follow up assessment.

  • Adherence to the prescribed exercise sessions' duration.

    The investigators will collect exercise session data recorded by the Polar Ignite watches worn by the participants in the intervention arm. The percentage of exercise time completed at the correct duration will be assessed.

    Will be evaluated after the 12-month follow up assessment.

  • Trial acceptability of the interventions and trial procedures via participant interviews

    Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.

    Interviews at 3 months

  • Trial acceptability of the interventions and trial procedures via participant interviews

    Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.

    Interviews at 6 months

  • Trial acceptability of the interventions and trial procedures via participant interviews

    Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.

    Interviews at 12 months

Secondary Outcomes (13)

  • Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).

    Baseline, 3-, 6- and 12 month follow up post randomisation

  • Physical activity and sedentary behaviour

    The Actigraph will be worn during the baseline assessment and the 3-, 6, and 12-month follow up post randomisation.

  • Exercise frequency and intensity

    It will be completed monthly from baseline to the 12-month follow up period to assess change over time.

  • Cardiovascular disease risk using the Second Manifestations of Arterial disease (SMART) risk score

    Measured at baseline, 3-, 6- and 12-month follow up

  • Cardiac specific quality of life using the MacNew Quality of Life Questionnaire

    Baseline, 3-, 6-, and 12-months post randomisation.

  • +8 more secondary outcomes

Study Arms (2)

Home-based Watch Intervention

EXPERIMENTAL

The home-based watch group will receive an exercise consultation with an exercise physiologist followed by check-in sessions at 1-month, 3-months, 6-months, and 12-months post-randomisation to set and review exercise and physical activity goals. They will wear a Polar Ignite wearable activity monitor which will help to monitor and guide their exercise sessions. Text-message feedback will be provided by an exercise physiologist based on information gathered from exercise sessions recorded on the watch by the participant.

Device: Polar Ignite Wearable Activity Monitor

Best Practice Usual Care Control

NO INTERVENTION

No intervention will be administered. Best practice usual care and activity.

Interventions

Polar Ignite Wearable Activity MonitorDEVICE

A wearable activity monitor capable of monitoring outcomes relating to physical activity sedentary time, heart rate, and sleep quality. The watch synchronises to a corresponding mobile app called Polar Flow- Sync and Analyze or to the Polar FlowSync data transfer software on a computer.

Home-based Watch Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed coronary heart disease.
  • Completed community cardiac rehabilitation.
  • Clinically stable (symptoms and medication).
  • Men and women aged over 18.
  • Access to smartphone with Bluetooth capacity or a computer/laptop.
  • Able to provide informed consent.

You may not qualify if:

  • Absolute contraindications to exercise as per international clinical guidelines.
  • Any serious mental health/cognitive issue that will prevent engagement with study procedures or increase the risk of exercise complications.
  • Diagnosed atrial fibrillation or other arrhythmia preventing accurate heart rate measurement.
  • Allergy to watch materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Limited

Coventry, West Midlands, CV1 3LN, United Kingdom

Location

Related Publications (1)

  • Denton F, Waddell A, Kite C, Hesketh K, Atkinson L, Cocks M, Jones H, Randeva H, Davenport N, Powell R, Clark C, Kyrou I, Harwood AE, McGregor G. Remote maintenance cardiac rehabilitation (MAINTAIN): A protocol for a randomised feasibility study. Digit Health. 2023 Feb 15;9:20552076231152176. doi: 10.1177/20552076231152176. eCollection 2023 Jan-Dec.

    PMID: 36818155DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Gordon McGregor, PhD

    Coventry University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher carrying out the follow up assessments will be blinded to the arm participants have been randomised to.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Investigator

Study Record Dates

First Submitted

December 16, 2021

First Posted

March 23, 2022

Study Start

March 28, 2022

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)