An Early Phase 1 interventional study of ACTIVE-CR in Cardiovascular Diseases, sponsored by University of Bath. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by University of Bath · Early Phase 1, Interventional, and Treatment
Cardiac rehabilitation (CR) is a comprehensive, long-term secondary care programme offered to individuals after a heart attack to aid recovery and prevent further illness. If properly implemented, CR is highly effective at reducing cardiac mortality, re-event, and re-admissions. Despite the well-established benefits, less than 50% of eligible UK patients enrol on a CR program. Among those who do begin CR in the UK, drop-out rates of 12-55% have been reported. If the take up of CR were increased to 65% it would reduce readmissions by a third and save approximately £100 million per year.
Physical activity (PA) is the cornerstone of CR. With recent advances in wearable activity monitors, accurate and objective assessment of free-living PA is now possible. It is increasingly apparent that the health benefits of PA can be achieved in many ways, and multiple dimensions (or aspects) of PA are independently important. The most sophisticated wearable devices can be used to capture these different dimensions and provide a more comprehensive evaluation of free-living PA - enabling patients to understand their individual PA in the context of guidelines - and offering more behavioural options and personalised advice.
In prior work, the investigators have developed a digital system for patients to self-manage their PA. This system comprises a wearable wrist-mounted accelerometer, bespoke digital platform, plus remote virtual support. The digital system has been customised for CR based on qualitative research in cardiac patients and practitioners - who found PA feedback to be understandable and motivating - and a route to address barrier to taking part in CR. This study aims to examine the feasibility of delivering a 6-week trial of a remote, technology-enabled physical activity intervention to patients who were unable to take up or dropped out of CR in the last 12 months.
Current provision of cardiac rehabilitation in the UK is only taken up by \<50% of eligible patients, despite the importance of attending for managing symptoms, reducing hospital readmissions and mortality, and improving quality of life. Widely reported factors related to non-attendance include employment commitments, difficulties with transport, lack of time, distance to travel and embarrassment related to attending rehabilitation. The use of home-based programmes permits greater flexibility of CR delivery, as patients are able to complete their programme at a place and time that suit them, as well as increasing access for those who are unable to travel or do not live in close proximity to face-to-face classes. However, current home-based approaches are lacking in objective monitoring of patients and strategies to increase physical activity are limited, despite it being a core component of CR. It is increasingly apparent that the health benefits of physical activity can be achieved in many ways, and multiple dimensions (or aspects) of physical activity are independently important.
Our past research shows that many people misjudge their physical activity status because they do not have access to accurate personalised information. With recent advances in wearable activity monitors, accurate and objective assessment of daily physical activity is possible. The most sophisticated wearable devices can now be used to capture multiple dimensions of physical activity and thus improve the depth and quality of feedback provided to individuals. To date, technology-based physical activity interventions in CR have primarily targeted unidimensional physical activity outcomes, such as step counts and sedentary behaviour.
Multidimensional feedback provides greater awareness, insight, and a more complete understanding of personal physical activity; enabling individuals to take greater responsibility for managing their behaviour and in the context of physical activity guidelines. In addition, a multidimensional approach offers more behavioural options and personalised advice.
Therefore, this study aims to examine the feasibility of delivering a 6-week trial of a remote, technology-enabled physical activity intervention to patients who were unable to take up or dropped out of CR. This study addresses several further shortcomings of previous research in this area: 1) the lack of grounding in psychological behaviour change theory, 2) the lack of objective monitoring for physical activity in CR, and 3) the need for support from practitioners and/or trainers to facilitate physical activity behaviour change.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 928 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Bath is the lead sponsor of 94 studies on the registry; 20 are open to participants now.
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Inclusion Criteria: Patients will be recruited in line with British Association for Cardiovascular Prevention and Rehabilitation (BACPR) guidelines, which states that the following priority patient groups shall be offered CR irrespective of age, sex, ethnic group, and clinical condition:
Other patient groups known to benefit:
Participants must also:
Exclusion Criteria: Patients who were not referred/deemed eligible for CR (assessed by clinical care team)
Participants will complete a 6-week remote, technology-based physical activity intervention named ACTIVE-CR, in which they will be required to wear a wrist worn monitor to measure daily physical activity. Participants will be able to view their physical activity feedback on a web-based platform and will receive three online trainer sessions across the 6 weeks to help them to understand and interpret their data.
Behavioral: ACTIVE-CR
Participants in the control group will receive usual care from their healthcare team (if relevant) and will be invited to have an assessment at baseline and 6-weeks. Control participants will not receive any form of intervention. At the end of the study, control participants will receive a summary of their physical activity data measured at baseline and 6-weeks (in a booklet format with guidance on how to interpret and use the information).
The ACTIVE-CR intervention comprises three key components: a wrist-worn physical activity monitor, a web-based platform providing physical activity feedback, and three autonomy supportive online trainer sessions. Each component is grounded by multiple established behaviour change techniques consistent with the behaviour change taxonomy developed by Michie et al. (2013). The barriers to physical activity were identified in our previous work and are consistent with previous literature
Feasibility: study recruitment
Assess recruitment rates, defined as the proportion of eligible patients who accept the invitation to participate in the study.
Time frame: 6-weeks
Feasibility: retention
Examine retention and adherence: defined as the proportion of participants who complete the study
Time frame: 6-weeks
Feasibility: adherence
Examine adherence: defined as the proportion of online trainer sessions completed and platform usage
Time frame: 6-weeks
Feasibility: acceptability
Explore the acceptability of the ACTIVE-CR intervention (in terms of affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy) using The Theoretical Framework of Acceptability (TFA) Questionnaire
Time frame: 6-weeks
Seven day physical activity measurement using a research grade device
A wrist worn physical activity monitor will be used to quantify the following physical activity measures derived from energy expenditure: sedentary time, and light, moderate, vigorous and very vigorous intensities of activity
Time frame: 6-weeks
Weight
Kilograms
Time frame: 6-weeks
Height
Centimetres
Time frame: 6-weeks
Waist circumference
Centimetres
Time frame: 6-weeks
Systolic and diastolic blood pressure
Measured in millimetres of mercury (mmHg)
Time frame: 6-weeks
Cholesterol levels (Low-density lipoproteins, high-density lipoproteins, total cholesterol)
Measured in millimoles per litre of blood
Time frame: 6-weeks
Triglyceride levels
Measured in millimoles per litre of blood
Time frame: 6-weeks
Functional capacity
Measured by the 6-minute walk test (metres)
Time frame: 6-weeks
Hospital Anxiety and Depression Scale
Score 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe."
Time frame: 6-weeks
Dartmouth COOP Functional Assessment Charts
Overall quality of life, physical function, social function, pain. 9 questions, each with answers ranging from 1-5. Possible scores 9-45. The higher the score, the worse the outcome
Time frame: 6-weeks
Behavioural Regulation in Exercise Questionnaire-3
Time frame: 6-weeks
The Exercise Self-Efficacy Scale
Rating of participant's degree of confidence to 18 statements by recording a number from 0 to 100% for each one. The higher the score, the higher the degree of confidence.
Time frame: 6-weeks
International Physical Activity Questionnaire
Self-report measure for physical activity
Time frame: 6-weeks
Health Care Climate Questionnaire (short-form)
6 items, used to assess participant's perceptions of the degree to which their trainer was autonomy supportive. The scale ranges from 1-7 (scores therefore range from 6-42). The higher the score, the better the participant's perception of support from the trainer
Time frame: 6-weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Mar 2024, 10 months.
Of 41 non-industry phase 1 interventional studies under Cardiovascular Diseases, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 67. This study's 10 months is below that.
Counting every sponsor, half of 86 studies reached it within 16 months; a quarter within 3 and three quarters within 54.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Bath