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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| South Eastern Health and Social Care Trust | OTHER |
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This study will evaluate the effect of a cardiac rehabilitation (CR) programme on blood protein molecules that may improve the function of arteries in coronary artery disease (CAD) patients who have suffered a heart attack. CAD patients who have either agreed or disagreed to take part in a CR programme will be recruited. This will allow a comparison of the study measurements between a group of patients who complete a CR programme and a group of patients who do not.
The other objective of this study is to perform interviews with the study participants and their significant others (i.e. spouse, family member, or a close friend) to listen to the reasons why patients agreed or disagreed to take part in a CR programme.
An exercise-based cardiac rehabilitation (CR) programme is an established method of secondary prevention of coronary artery disease (CAD). Moreover, there is a body of evidence that supports the ability of this intervention to reduce hospital readmissions and cardiovascular mortality. However, despite the proven benefit, CR programmes are underutilised worldwide. Moreover, the molecular mechanisms responsible for orchestrating the beneficial physiological adaptations induced by a CR programme are poorly understood.
Therefore, this study will evaluate the effect of a CR programme on novel molecular mechanisms and endothelial function in post-myocardial infarction CAD patients. Additionally, semi-structured interviews will be conducted with study participants and their significant others (i.e. spouse, family member, or a close friend) to explore the reasons why patients may agree or disagree to take part in a CR programme. Altogether, this study will provide physiological and detailed qualitative information that may help to provoke an increased participation in CR programmes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase-III Cardiac Rehabilitation | Eight weeks of supervised exercise sessions (one session per week). |
| |
| Phase-III and Phase IV Cardiac Rehabilitation | Twenty weeks of supervised exercise sessions (one session per week for first eight weeks [phase-III], session frequency determined by participant for remaining twelve weeks [phase-IV]. |
| |
| No Cardiac Rehabilitation | Participants who declined to take part in a cardiac rehabilitation programme. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise-based cardiac rehabilitation | Behavioral | Moderate intensity aerobic exercise, lifestyle advice, and psychological support. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Sirtuin 1 serum protein concentration | Measured in ng/mL | At baseline and after 22-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 serum protein concentration | Measured in pg/mL | Baseline, week-8, and week-22 |
| Interleukin-10 serum protein concentration | Measured in pg/mL |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative perspectives from study participants and their significant others regarding reasons for agreeing or declining to participate in a phase-III or phase-IV cardiac rehabilitation programme | Generated by semi-structured interviews | Week-8 or week-22 |
Inclusion Criteria:
Symptoms of ischaemia, such as: extreme fatigue, breathlessness, chest pain, and heart palpitations.
New or presumed new significant ST-segment-T wave changes or new left bundle branch block.
Development of pathological Q waves on the electrocardiogram.
Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
Identification of an intracoronary thrombus by angiography
Exclusion Criteria:
Patient Inclusion Criteria for Interview Component of Study:
Patient Exclusion Criteria for Interview Component of Study:
- Identified significant other refuses to participate or provide informed consent.
Significant Other Inclusion Criteria for Interview Component of Study:
Significant Other Exclusion Criteria for Interview Component of Study:
- Patient refuses to participate or provide informed consent.
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Post-myocardial infarction coronary artery disease patients who have been invited to participate in a phase-III cardiac rehabilitation programme with the Belfast Health and Social Care Trust or South Eastern Health and Social Care Trust.
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| Name | Affiliation | Role |
|---|---|---|
| Ciara Hughes, PhD | Ulster University | Study Director |
| Gareth Thompson, PhD student | Ulster University | Study Chair |
| Gareth Davison, PhD | Ulster University | Study Chair |
| Jacqui Crawford, BSc, MSc | Ulster University | Study Chair |
| Lisa Spratt | Belfast Health and Social Care Trust | Principal Investigator |
| Maureen Morrison | South Eastern Health and Social Care Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast Health and Social Care Trust (Belfast City Hospital, Mater Hospital, and Royal Victoria Hospital) | Belfast | Co. Antrim | BT9 7AB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33961501 | Derived | Thompson G, Wilson IM, Davison GW, Crawford J, Hughes CM. "Why would you not listen? It is like being given the winning lottery numbers and deciding not to take them": semi-structured interviews with post-acute myocardial infarction patients and their significant others exploring factors that influence participation in cardiac rehabilitation and long-term exercise training. Disabil Rehabil. 2022 Aug;44(17):4750-4760. doi: 10.1080/09638288.2021.1919213. Epub 2021 May 7. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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Serum Plasma Whole blood Lymphocytes
| Baseline, week-8, and week-22 |
| Sirtuin 1 messenger ribonucleic acid gene expression | Baseline, week-8, and week-22 |
| Interleukin-6 messenger ribonucleic acid gene expression | Baseline, week-8, and week-22 |
| Interleukin-10 messenger ribonucleic acid gene expression | Baseline, week-8, and week-22 |
| Erythrocyte sedimentation rate | Millimetres per hour | Baseline, week-8, and week-22 |
| Serum low-density lipoprotein value | Baseline, week-8, and week-22 |
| Serum total cholesterol value | Baseline, week-8, and week-22 |
| Serum triglyceride value | Baseline, week-8, and week-22 |
| Serum high-density lipoprotein value | Baseline, week-8, and week-22 |
| Lipid soluble antioxidants concentrations | Baseline, week-8, and week-22 |
| Lipid hydroperoxide concentration | Baseline, week-8, and week-22 |
| Ascorbyl free radicle concentration | Baseline, week-8, and week-22 |
| Brachial flow-mediated dilatation | Percentage increase in arterial diameter | Baseline, week-8, and week-22 |
| Arterial stiffness (finger photo-plethysmography technique) | Stiffness index | Baseline, week-8, and week-22 |
| Incremental Shuttle Walk Test | Distance walked (metres) | Baseline, week-8, and week-22 |
| Systolic and diastolic blood pressure | Millimetre of mercury | Baseline, week-8, and week-22 |
| Resting heart rate | Beats per minute | Baseline, week-8, and week-22 |
| Body mass index | Kilograms per metre squared | Baseline, week-8, and week-22 |
| Waist circumference | Centimetres | Baseline, week-8, and week-22 |
| South Eastern Health and Social Care Trust (Ulster Hospital) | Dundonald | Co. Down | BT16 1RH | United Kingdom |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001519 | Behavior |