Specialty: Diabetes, Primary sub-specialty: Both
Conditions
Interventions
Eligible participants will be randomised, apart from those in the same household, using a block design and stratified by gender (men
other) to one of two groups.
Control group: Participants will be provided with general health advice in the form of a British Heart Foundation standard information leaflet and will be
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 13/02/2019: 1. Aged 18 years or older 2. 12-48 months post confirmed diagnosis of a cardiac event (myocardial infarction, angina or acute coronary syndrome) 3. Able to speak and read English to participate effectively in a group education programme 4. Willing and able to attend the education sessions and clinic visits 5. Willing and able to give informed consent 6. Access to a mobile phone in order to receive text messages 7. Willingness to allow GP notification of their participation in study and access to patient records for purpose of study 8. Able to take part in moderate physical activity as assessed using Incremental Shuttle Walk Test (ISWT) (Level three or above) Previous participant inclusion criteria: 1. Aged 18 years or older 2. 12-36 months post confirmed diagnosis of a cardiac event (myocardial infarction, angina or acute coronary syndrome) 3. Able to speak and read English to participate effectively in a group education programme 4. Willing and able to attend the education sessions and clinic visits 5. Willing and able to give informed consent 6. Access to a mobile phone in order to receive text messages 7. Willingness to allow GP notification of their participation in study and access to patient records for purpose of study 8. Able to take part in moderate physical activity as assessed using Incremental Shuttle Walk Test (ISWT) (Level three or above)
Exclusion criteria
Exclusion criteria: 1. Individuals with a diagnosis of heart failure where the underlying primary cause is not myocardial disease as a result of atherosclerosis will be excluded from this study 2. Musculoskeletal limitations that would limit physical activity (e.g. musculoskeletal injury) 3. Participation in another clinical intervention study in the past 12 weeks 4. Lacks capacity to give informed consent 5. Severe life-threatening co-morbidity (e.g. malignancy) 6. Poor exercise capacity, (< level three on the ISWT [120 metres]), these individuals will be directed back into cardiac rehabilitation (good practice) 7. Housebound or immobile 8. Unstable symptoms (chest pain or breathlessness at rest; unstable stage II hypertension [160/100mmHg], not on necessary medications) 9. Individuals with no or limited understanding of written or verbal English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily physical activity is assessed using an accelerometer (Average daily physical activity - Milligravities [mg]) worn for eight days at baseline, 6 and 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Aerobic fitness is assessed using an Incremental Shuttle walk test (metres) at baseline and 12 months 2. Anthropometric measures of height, body mass, BMI, waist circumference, hip circumference and waist to hip ratio are measured using standard techniques at baseline and 12 months 3. Blood pressure (mmHg) & resting heart rate (bpm) are measured using standard techniques at baseline and 12 months 4. Lipid profile (Cholesterol, HDL, LDL, Triglycerides) is measured via venepuncture at baseline and 12 months 5. HbA1c (mmol/mol, %) is measured via venepuncture at baseline and 12 months 6. Self-efficacy for exercise expectations is measured using the Jenkins self-efficacy for exercise expectations scale at baseline, 6 and 12 months 7. Anxiety and depression is measured using the Hospital Anxiety and Depression scale (HADS) at baseline, 6 and 12 months 8. Self-reported physical activity is measured using the Recent Physical Activity Questionnaire (RPAQ) at baseline, 6 and 12 months 9. Quality of life is measured using the EuroQoL EQ-5D-5L at baseline, 6 and 12 months 10. Chronotype is measured using the Morningness- Eveningness Questionnaire at baseline, 6 and 12 months 11. Biomarkers of inflammation, proteomics, metabolomics and novel markers of cardiovascular health are measured via venepuncture at baseline and 12 months The following secondary outcome measure was added on 13/02/2019: 12. Health service use data at 12 months using routinely used questions (approved by a health economist) is collected annually for 5 years using GP, hospital records and/ or NHS Digital. | — |
Countries
England, United Kingdom
Outcome results
None listed