An interventional study of Polar Ignite Wearable Activity Monitor in Coronary Heart Disease, sponsored by Coventry University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-20.
Sponsored by Coventry University · Not applicable, Interventional, and Basic science
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.
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.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's enrollment of 30 is below the median of 160 across 778 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →Coventry University is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No intervention will be administered. Best practice usual care and activity.
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 feasibility assessed via recruitment rate.
The investigators will complete enrolment logs to record the number of people who enrol in the study.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Interviews at 12 months
Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).
To assess heart rate and rating of perceived exertion over a 15 meter shuttle walk. Increases in distance walked indicates a higher exercise capacity. Changes in distance walked will be compared to participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6- and 12 month follow up post randomisation
Physical activity and sedentary behaviour
Using an Actigraph to measure free-living sedentary behaviour and physical activity behaviour. Changes in physical activity and sedentary behaviour will be compared to participants randomised to the intervention vs the control group over time.
Time frame: The Actigraph will be worn during the baseline assessment and the 3-, 6, and 12-month follow up post randomisation.
Exercise frequency and intensity
The Godin Leisure Time Exercise Questionnaire will be completed monthly to assess the frequency of 3 different exercise intensities over a week. Changes in exercise frequency and intensity will be compared to participants randomised to the intervention vs the control group over time. The questionnaire is broken down into strenuous, moderate, and mild physical activity completed in bouts of 15 minutes or more over the last week. A higher score indicates a more active individual and a lower score indicates a less active individual.
Time frame: 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
A score taking into account cardiovascular history, smoking, blood pressure, and measures from blood samples including a full lipid profile, estimated glomerular filtration rate and high-sensitivity C-reactive protein. It identifies patients at a high risk of a reoccurring vascular event within 10 years. Changes in the risk score will be compared to participants randomised to the intervention vs the control group over time.
Time frame: Measured at baseline, 3-, 6- and 12-month follow up
Cardiac specific quality of life using the MacNew Quality of Life Questionnaire
Using the MacNew Quality of Life Questionnaire to assess health-related quality of life. 1 indicates low health-related quality of life and 7 indicates high quality of life. Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Depression using the Patient Health Questionnaire (PHQ-9)
Scores represent mild (0-5, moderate (6-10), moderately severe (11-15) and severe depression (16-20). Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Anxiety using the Generalised Anxiety Disorder 7-item Scale (GAD-7)
A self report questionnaire to measure generalised anxiety disorder. Scores represent mild (0-5), moderate (6-10), moderately severe anxiety (11-15), and severe anxiety (15-21). Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Self efficacy using the General Self-Efficacy Scale (GSE)
A 10-item psychometric scale to assess optimistic self-beliefs to cope with a range of life demands. Total scores can range from 10 up to 40. A higher score indicates a higher level of self-efficacy. Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Patient activation using the Patient Activation Measure
Higher levels of activation are linked to positive health behaviours and outcomes. Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Health utility using the EQ-5D-5L
The responses to the questionnaire can be converted into a health utility score using 5 levels to define a health state. Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Health and social care resource use using the Client Service Receipt Inventory (CSRI)
We will use a health and social care resource use questionnaire to examine the feasibility of collecting these data and refine resource use schedules for use in a definitive trial. We will also test the feasibility of collecting patient-reported health outcome data. Scores will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Cost of the study
Cost of staff, the facility, consumables etc. of delivering active and control interventions. Costs will be compared between participants randomised to the intervention vs the control group.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Safety assessed via adverse and serious adverse events
Events will be documented in accordance with Good Clinical Practice (GCP). Adverse and serious adverse events will be compared between participants randomised to the intervention vs the control group over time.
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Plan to share: No
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Coventry University