Clinical trial NCT05292287: Remote Maintenance Cardiac Rehabilitation
Official title: Remote Maintenance Cardiac Rehabilitation: a Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Exercise Maintenance
Cardiac Rehabilitation
Home-based Exercise
Wearable Activity Monitor
Lead sponsor: Coventry University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Intervention feasibility assessed via recruitment rate.
timeFrame: Will be evaluated after the 12-month follow up assessment
measure: Intervention feasibility assessed via number of screened patients.
timeFrame: Will be evaluated after the 12-month follow up assessment
measure: Intervention feasibility assessed via number of patients randomised.
timeFrame: Will be evaluated after the 12-month follow up assessment
measure: Intervention feasibility assessed via number of patients retained in the study.
timeFrame: Will be evaluated after the 12-month follow up assessment
measure: Adherence to the prescribed exercise sessions.
timeFrame: Will be evaluated after the 12-month follow up assessment.
measure: Adherence to the prescribed exercise sessions' intensity.
timeFrame: Will be evaluated after the 12-month follow up assessment.
measure: Adherence to the prescribed exercise sessions' duration.
timeFrame: Will be evaluated after the 12-month follow up assessment.
measure: Trial acceptability of the interventions and trial procedures via participant interviews
timeFrame: Interviews at 3 months
measure: Trial acceptability of the interventions and trial procedures via participant interviews
timeFrame: Interviews at 6 months
measure: Trial acceptability of the interventions and trial procedures via participant interviews
timeFrame: Interviews at 12 months
Secondary outcomes:
measure: Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).
timeFrame: Baseline, 3-, 6- and 12 month follow up post randomisation
measure: Physical activity and sedentary behaviour
timeFrame: The Actigraph will be worn during the baseline assessment and the 3-, 6, and 12-month follow up post randomisation.
measure: Exercise frequency and intensity
timeFrame: It will be completed monthly from baseline to the 12-month follow up period to assess change over time.
measure: Cardiovascular disease risk using the Second Manifestations of Arterial disease (SMART) risk score
timeFrame: Measured at baseline, 3-, 6- and 12-month follow up
measure: Cardiac specific quality of life using the MacNew Quality of Life Questionnaire
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Depression using the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Anxiety using the Generalised Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Self efficacy using the General Self-Efficacy Scale (GSE)
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Patient activation using the Patient Activation Measure
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Health utility using the EQ-5D-5L
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Health and social care resource use using the Client Service Receipt Inventory (CSRI)
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Cost of the study
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
measure: Safety assessed via adverse and serious adverse events
timeFrame: Baseline, 3-, 6-, and 12-months post randomisation.
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: Atrium Health Limited
state: West Midlands
Study officials:
affiliation: Coventry University
name: Gordon McGregor, PhD
role: PRINCIPAL_INVESTIGATOR
References: