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NCT Number: NCT01147952

The Effect of Exercise on Peripheral Blood Gene Expression in 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.

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Key information

Conditions

Angina Pectoris Anxiety Disorders Behavior Behavioral Symptoms Cardiovascular Diseases Chest Pain Depression Heart Diseases Mental Disorders Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NIHR Cardiovascular Biomedical Research Unit

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Structured Exercise Training

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.

Primary outcomes

  1. Peripheral blood gene expression

    Time frame: baseline

  2. Peripheral blood gene expression

    Time frame: 6wks after starting 12week exercise training (or conventional care)

  3. peripheral blood gene expression

    Time frame: 12 weeks after exercise training (or conventional care)

  4. Peripheral blood gene expression

    Time frame: 24 weeks after starting 12 weeks exercise training programme

Secondary outcomes

  1. Angina status

    Time frame: baseline

  2. Angina status

    Time frame: 6wks after starting 12 week exercise programme (or conventional care)

  3. Angina status

    Time frame: 12wks after starting 12 week exercise programme (or conventional care)

  4. Angina Status

    Time frame: 24wks after starting 12 week exercise programme (or conventional care)

  5. Anxiety Score

    Time frame: baseline

  6. Anxiety Score

    Time frame: 6wks after starting 12 week exercise programme (or conventional care)

  7. Anxiety Score

    Time frame: 12wks after starting 12 week exercise programme (or conventional care)

  8. Anxiety Score

    Time frame: 24wks after starting 12 week exercise programme (or conventional care)

  9. Depression Score

    Time frame: 6wks after starting 12 week exercise programme (or conventional care)

  10. Depression Score

    Time frame: baseline

  11. Depression Score

    Time frame: 12wks after starting 12 week exercise programme (or conventional care)

  12. Depression Score

    Time frame: 24wks after starting 12 week exercise programme (or conventional care)

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 22, 2010
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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