Background
Physical activity in the prevention of subsequent CHD events
Lifestyle education and remote text-message support
Methods
Aims and objectives
Study overview
Participant invitation and recruitment
Measurement type | Measurement (units) | Baseline | 6 months | 12 months | |
---|---|---|---|---|---|
Screening | Demographic data | Date of birth, age, gender, ethnicity, | x | ||
smoking status, alcohol status employment status | x | x | |||
Health history | Type of cardiac event defining as eligible, date of CHD diagnosis, | X | |||
medical history and medications, whether family history of CHD | x | x | |||
Primary outcome measure | Physical activity | Accelerometer (average daily physical activity - milli-gravitational units (mg)) | x | x | x |
Secondary outcome measures | Aerobic fitness | Incremental Shuttle Walk Test (metres) | x | x | |
Anthropometric | Height (cm) and body mass (kg) | x | x | ||
Body Mass Index (kg/m2) | |||||
Waist circumference (cm) | |||||
Hip circumference (cm) | |||||
Waist to hip ratio | |||||
Cardiovascular | Blood pressure (mmHg) and resting heart rate (bpm) | x | x | ||
Blood samples (all non-fasting) | Lipid profile (cholesterol, HDL, LDL, triglycerides) | x | x | ||
HbA1c (mmol/mol, %) | |||||
Questionnaires | Jenkins Self-efficacy for Exercise Expectations Scale [45] | x | x | x | |
Hospital Anxiety and Depression Scale (HADS) [58] | x | x | x | ||
x | x | x | |||
Recent Physical Activity Questionnaire (RPAQ) [40] | x | x | x | ||
x | x | x | |||
x | |||||
Exploratory endpoint | Stored serum and plasma samples | Biomarkers of inflammation, proteomics, metabolomics and novel markers of cardiovascular health | x | x |
Eligibility criteria
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Aged 18 years or older
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Be 12–48 months post confirmed diagnosis of a cardiac event (myocardial infarction, angina or acute coronary syndrome)
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Able to speak and read English in order to participate effectively in a group education programme
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Willing and able to attend the education sessions and clinic visits
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Willing and able to give informed consent
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Access to a mobile phone in order to receive text messages
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Willing to allow their GP notification of their participation in the study and access to patient records for purpose of the study
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Able to take part in moderate physical activity as assessed using the ISWT (level 3 or above (120 m)) [27]
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A diagnosis of heart failure where the underlying primary cause is not myocardial disease as a result of atherosclerosis
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Musculoskeletal limitations that limit physical activity (e.g. musculoskeletal injury)
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Participating in another clinical intervention study or have done so in the past 12 weeks
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A severe life-threatening co-morbidity (e.g. malignancy)
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Poor exercise capacity, (< level 3 on the ISWT (120 m)) [27]
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Housebound or immobile
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Unstable symptoms (chest pain or breathlessness at rest; unstable stage II hypertension (160/100 mmHg), not on necessary medications)
Algorithm for exclusion of individuals with poor exercise capacity and unstable symptoms
Randomisation
Treatment regimens
Control group
Intervention group
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What is CHD?
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Risks and how to reduce these risks to maintain a healthy heart
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The benefits of physical activity on CHD
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The importance of medication and healthy eating
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Improving confidence and personal motivation to increase physical activity
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Recognition of the personal barriers and facilitators to physical activity
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How to assess and goal plan physical activity using a self-monitoring tool (the participant is given a pedometer and activity diary to help with self-monitoring)