The Effect of Exercise on Peripheral Blood Gene Expression in Angina

NCT01147952 | Completed DMC

• 1 other identifier: STH15565
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

angina; gene expression; depression; anxiety

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

Study Arms (2)

12 week exercise training

EXPERIMENTAL

Behavioral: Structured exercise training

Conventional Care

NO INTERVENTION

Interventions

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.

12 week exercise training

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

NIHR Cardiovascular Biomedical Research Unit

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20955605 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 22, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)