Coronary Heart DiseaseMAINTAINNCT05292287
Remote Maintenance Cardiac Rehabilitation
A study testing Polar Ignite Wearable Activity Monitor in people with Coronary Heart Disease, run by Coventry University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Polar Ignite Wearable Activity Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 15 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Atrium Health Limited
Coventry, West Midlands, CV1 3LN
About this study
Official title: Remote Maintenance Cardiac Rehabilitation: a Randomised Feasibility Study
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.
Read the 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
- Being tested
- Polar Ignite Wearable Activity Monitor
- Keywords
- Coronary Heart Disease, Exercise Maintenance, Cardiac Rehabilitation, Home-based Exercise, Wearable Activity Monitor
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polar Ignite Wearable Activity Monitor |
| Best Practice Usual Care Control | No intervention | No intervention will be administered. Best practice usual care and activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility assessed via recruitment rate.
The investigators will complete enrolment logs to record the number of people who enrol in the study.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Interviews at 12 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3-, 6-, and 12-months post randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start28 Mar 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Denton, Coventry University
- Investigators
- Gordon McGregor, PhD, Principal investigator, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292287
- Sponsor's protocol ID
- 302243
- Other IDs
- 121990
- Acronym
- MAINTAIN
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2021
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36818155
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Maintenance Cardiac Rehabilitation: a Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT05292287
- Acronym / sponsor ID
- MAINTAIN / 302243
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, Exercise Maintenance, Cardiac Rehabilitation, Home-based Exercise, Wearable Activity Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based Watch Intervention | Experimental | Device: Polar Ignite Wearable Activity MonitorThe 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. |
| Best Practice Usual Care Control | No intervention | –No intervention will be administered. Best practice usual care and activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polar Ignite Wearable Activity MonitorA 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. | Device | Home-based Watch Intervention |
Primary outcome
Intervention feasibility assessed via recruitment rate.
Time frame: Will be evaluated after the 12-month follow up assessment
The investigators will complete enrolment logs to record the number of people who enrol in the study.
Intervention feasibility assessed via number of screened patients.
Time frame: Will be evaluated after the 12-month follow up assessment
The investigators will complete screening logs to record the number of eligible participants.
Intervention feasibility assessed via number of patients randomised.
Time frame: Will be evaluated after the 12-month follow up assessment
The investigators will complete randomisation logs to record the number of participants randomised to both groups.
Intervention feasibility assessed via number of patients retained in the study.
Time frame: Will be evaluated after the 12-month follow up assessment
The investigators will assess the number of participants who withdraw or stay within the study.
Adherence to the prescribed exercise sessions.
Time frame: Will be evaluated after the 12-month follow up assessment.
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.
Adherence to the prescribed exercise sessions' intensity.
Time frame: Will be evaluated after the 12-month follow up assessment.
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.
Adherence to the prescribed exercise sessions' duration.
Time frame: Will be evaluated after the 12-month follow up assessment.
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.
Trial acceptability of the interventions and trial procedures via participant interviews
Time frame: Interviews at 3 months
Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.
Trial acceptability of the interventions and trial procedures via participant interviews
Time frame: Interviews at 6 months
Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.
Trial acceptability of the interventions and trial procedures via participant interviews
Time frame: Interviews at 12 months
Qualitative semi-structured interviews carried out with control and intervention participants as well as interviews with participants who withdraw from the study.
13 secondary outcomes
Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).
Time frame: Baseline, 3-, 6- and 12 month follow up post randomisation
Physical activity and sedentary behaviour
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
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
Time frame: Measured at baseline, 3-, 6- and 12-month follow up
Cardiac specific quality of life using the MacNew Quality of Life Questionnaire
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Depression using the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Anxiety using the Generalised Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Self efficacy using the General Self-Efficacy Scale (GSE)
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Patient activation using the Patient Activation Measure
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Health utility using the EQ-5D-5L
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Health and social care resource use using the Client Service Receipt Inventory (CSRI)
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Cost of the study
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Safety assessed via adverse and serious adverse events
Time frame: Baseline, 3-, 6-, and 12-months post randomisation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 36818155Denton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon McGregor, PhD principal investigator
Coventry University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polar Ignite Wearable Activity Monitor in people with Coronary Heart Disease, run by Coventry University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility assessed via recruitment rate. (time frame: Will be evaluated after the 12-month follow up assessment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.