The Effect of Exercise on Peripheral Blood Gene Expression in Angina

Study Overview
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Brief Summary
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Regular exercise is known to produce significant health benefits and to reduce the risk of heart diseases, although how this benefit occurs is not well understood. White blood cells are known to be involved in triggering heart attacks, and which genes are switched on or off in white blood cells determines whether they have beneficial or harmful effects. Previous studies, and studies ongoing in our group, have demonstrated measurement of peripheral blood gene expression (which reflects white blood cell gene expression) is able to distinguish between patients with and without coronary artery disease, or patients who are able to develop good compared with poor coronary collateral arteries. Therefore, the gene expression signature in peripheral blood may provide novel diagnostic or prognostic information, and insight into the pathogenesis of heart disease. We therefore hypothesise that exercise alters peripheral blood gene expression in patients with coronary artery disease and angina. This will identify possible ways that exercise improves angina and reduces the risk of heart disease.

Official Title
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A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina

Conditions
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Angina Pectoris

Intervention / Treatment
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* Behavioral: Structured exercise training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Class I to III angina pectoris (classified according to the Canadian Cardiovascular Society [CCS])with documented myocardial ischemia or coronary artery disease on angiography Ability to read and speak English to a level allowing satisfactory completion of written questionnaires and to understand instruction during the exercise programme. Exclusion Criteria: Acute coronary syndromes or recent myocardial infarction (<2 months) Left main coronary artery stenosis >25% or high-grade proximal left anterior descending artery stenosis Known reduced left ventricular function (ejection fraction <40%) Significant valvular heart disease Insulin-dependent diabetes mellitus Occupational, orthopedic, and other conditions that preclude regular exercise Patients whose ECG prevents interpretation of an exercise test (LBBB, RBBB, pacemaker implantation). Patients who already perform greater than 30min continuous exercise three times weekly (self-reported).

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12 week exercise training<br> | Behavioral: Structured exercise training<br>* randomised to 12 weeks of exercise training up to three times weekly. Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.<br>|
| No Intervention: Conventional Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral blood gene expression |  | baseline | 
| Peripheral blood gene expression |  | 6wks after starting 12week exercise training (or conventional care) | 
| peripheral blood gene expression |  | 12 weeks after exercise training (or conventional care) | 
| Peripheral blood gene expression |  | 24 weeks after starting 12 weeks exercise training programme | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angina status |  | baseline | 
| Angina status |  | 6wks after starting 12 week exercise programme (or conventional care) | 
| Angina status |  | 12wks after starting 12 week exercise programme (or conventional care) | 
| Angina Status |  | 24wks after starting 12 week exercise programme (or conventional care) | 
| Anxiety Score |  | baseline | 
| Anxiety Score |  | 6wks after starting 12 week exercise programme (or conventional care) | 
| Anxiety Score |  | 12wks after starting 12 week exercise programme (or conventional care) | 
| Anxiety Score |  | 24wks after starting 12 week exercise programme (or conventional care) | 
| Depression Score |  | 6wks after starting 12 week exercise programme (or conventional care) | 
| Depression Score |  | baseline | 
| Depression Score |  | 12wks after starting 12 week exercise programme (or conventional care) | 
| Depression Score |  | 24wks after starting 12 week exercise programme (or conventional care) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angina, gene expression, depression, anxiety