The Effect of Exercise on Peripheral Blood Gene Expression in Angina

NCT ID: NCT01147952

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

12 week exercise training

Group Type: EXPERIMENTAL

Structured exercise training

Intervention Type: BEHAVIORAL

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.

Conventional Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured exercise training

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NIHR Cardiovascular Biomedical Research Unit

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 20955605 (View on PubMed)

Other Identifiers

STH15565

Identifier Type: -

Identifier Source: org_study_id