The Effect of Exercise on Peripheral Blood Gene Expression in Angina

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

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.

Study Overview

• Status: Completed
• Conditions: Angina Pectoris
• Intervention / Treatment: Behavioral: Structured exercise training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • NIHR Cardiovascular Biomedical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12 week exercise training	Behavioral: 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.
No Intervention: Conventional Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: depression; angina; anxiety; gene expression
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: STH15565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No