Remote Maintenance Cardiac Rehabilitation

NCT ID: NCT05292287

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-02-15

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.

Detailed Description

Following the completion of centre-based cardiac rehabilitation (CR), lifetime adoption of physical activity (PA) and adherence to exercise is often poor. Wearable activity monitors may be a tool to remotely prescribe and monitor PA and exercise to promote long term behaviour change. This research aims to assess the feasibility of conducting a randomised controlled trial (RCT) testing a remotely prescribed and monitored long-term maintenance exercise programme in cardiac rehabilitation graduates with coronary heart disease (CHD). 30 participants with CHD will be recruited to a 12-month feasibility RCT and randomised into 2 arms: 1) a home-based watch intervention group and 2) a best practice usual care control group. The intervention group will receive an initial exercise consultation, personalised exercise prescription delivered via a Polar Ignite watch, and monitoring via check-ins and feedback text-message support with a clinical exercise physiologist. The control group will receive no intervention. All participants will undergo assessment at baseline (following the completion of CR) and at 3 follow up time points including 3-, 6- and 12-months. The primary outcome will be to assess feasibility and other process-related outcomes. The secondary outcomes will include exercise capacity, physical activity and sedentary behaviour, exercise time, cardiovascular disease risk, quality of life, depression, anxiety, self-efficacy, patient activation, health utility, health and social care resource use, cost, and adverse and serious adverse events. Semi-structured interviews will be conducted at 3-, 6-, and 12-months post-randomisation to explore the views, perceptions, acceptability, and experiences of the remotely prescribed and monitored exercise intervention and trial procedures. Participants who drop out or choose not to participate will be offered a semi-structured interview or a questionnaire, respectively, to understand feasibility. Overall, there is a need to support people post-CR to remotely maintain PA and exercise behaviour for secondary prevention of CHD particularly during the era of government-enforced restrictions or lockdowns due to the COVID-19 pandemic. The MAINTAIN study will assess the feasibility of longer-term remote prescription and monitoring of maintenance exercise following CR using a wearable activity monitor and text message support compared to best practice usual care for people diagnosed with CHD.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Home-based Watch Intervention

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.

Group Type: EXPERIMENTAL

Polar Ignite Wearable Activity Monitor

Intervention Type: DEVICE

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.

Best Practice Usual Care Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Polar Ignite Wearable Activity Monitor

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coventry University

OTHER

Sponsor Role: lead

Responsible Party

Francesca Denton

Chief Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gordon McGregor, PhD

Role: PRINCIPAL_INVESTIGATOR

Coventry University

Locations

Atrium Health Limited

Coventry, West Midlands, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36818155 (View on PubMed)

Other Identifiers

121990

Identifier Type: OTHER

Identifier Source: secondary_id

302243

Identifier Type: -

Identifier Source: org_study_id