Remote Maintenance Cardiac Rehabilitation (MAINTAIN)

August 19, 2024 updated by: Francesca Denton, Coventry University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
    • West Midlands
      • Coventry, West Midlands, United Kingdom, CV1 3LN
        • Atrium Health Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: 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.
No Intervention: Best Practice Usual Care Control
No intervention will be administered. Best practice usual care and activity.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Will be evaluated after the 12-month follow up assessment
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.
Will be evaluated after the 12-month follow up assessment
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.
Will be evaluated after the 12-month follow up assessment
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.
Will be evaluated after the 12-month follow up assessment
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.
Will be evaluated after the 12-month follow up assessment.
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.
Will be evaluated after the 12-month follow up assessment.
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.
Will be evaluated after the 12-month follow up assessment.
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.
Interviews at 3 months
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.
Interviews at 6 months
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.
Interviews at 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise capacity determined using an Incremental Shuttle Walk Test (ISWT).
Time Frame: Baseline, 3-, 6- and 12 month follow up post randomisation
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.
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.
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.
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.
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.
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
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Baseline, 3-, 6-, and 12-months post randomisation.
Cost of the study
Time Frame: Baseline, 3-, 6-, and 12-months post randomisation.
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.
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.
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.
Baseline, 3-, 6-, and 12-months post randomisation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Coventry University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gordon McGregor, PhD, Coventry University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 302243
  • 121990 (Other Identifier: Coventry University Ethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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