Clinical trial NCT01147952: The Effect of Exercise on Peripheral Blood Gene Expression in Angina
Official title: A Randomised Trial of the Effect of Exercise on Peripheral Blood Gene Expression in Patients With Stable Angina
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angina Pectoris
Keywords: angina
gene expression
depression
anxiety
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Peripheral blood gene expression
timeFrame: baseline
measure: Peripheral blood gene expression
timeFrame: 6wks after starting 12week exercise training (or conventional care)
measure: peripheral blood gene expression
timeFrame: 12 weeks after exercise training (or conventional care)
measure: Peripheral blood gene expression
timeFrame: 24 weeks after starting 12 weeks exercise training programme
Secondary outcomes:
measure: Angina status
timeFrame: baseline
measure: Angina status
timeFrame: 6wks after starting 12 week exercise programme (or conventional care)
measure: Angina status
timeFrame: 12wks after starting 12 week exercise programme (or conventional care)
measure: Angina Status
timeFrame: 24wks after starting 12 week exercise programme (or conventional care)
measure: Anxiety Score
timeFrame: baseline
measure: Anxiety Score
timeFrame: 6wks after starting 12 week exercise programme (or conventional care)
measure: Anxiety Score
timeFrame: 12wks after starting 12 week exercise programme (or conventional care)
measure: Anxiety Score
timeFrame: 24wks after starting 12 week exercise programme (or conventional care)
measure: Depression Score
timeFrame: 6wks after starting 12 week exercise programme (or conventional care)
measure: Depression Score
timeFrame: baseline
measure: Depression Score
timeFrame: 12wks after starting 12 week exercise programme (or conventional care)
measure: Depression Score
timeFrame: 24wks after starting 12 week exercise programme (or conventional care)
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: NIHR Cardiovascular Biomedical Research Unit
state: South Yorkshire
Study officials:
References:
citation: Bourke L, Tew GA, Milo M, Crossman DC, Saxton JM, Chico TJ. Study protocol: a randomised controlled trial investigating the effect of exercise training on peripheral blood gene expression in patients with stable angina. BMC Public Health. 2010 Oct 18;10:620. doi: 10.1186/1471-2458-10-620.