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The Effect of Exercise on Peripheral Blood Gene Expression in Angina

Primary Purpose

Angina Pectoris

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Structured exercise training
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Angina Pectoris focused on measuring angina, gene expression, depression, anxiety

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • NIHR Cardiovascular Biomedical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

12 week exercise training

Conventional Care

Arm Description

Outcomes

Primary Outcome Measures

Peripheral blood gene expression
Peripheral blood gene expression
peripheral blood gene expression
Peripheral blood gene expression

Secondary Outcome Measures

Angina status
Angina status
Angina status
Angina Status
Anxiety Score
Anxiety Score
Anxiety Score
Anxiety Score
Depression Score
Depression Score
Depression Score
Depression Score

Full Information

First Posted
June 18, 2010
Last Updated
April 13, 2016
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01147952
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris
Keywords
angina, gene expression, depression, anxiety

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
12 week exercise training
Arm Type
Experimental
Arm Title
Conventional Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise training
Intervention Description
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 Outcome Measure Information:
Title
Peripheral blood gene expression
Time Frame
baseline
Title
Peripheral blood gene expression
Time Frame
6wks after starting 12week exercise training (or conventional care)
Title
peripheral blood gene expression
Time Frame
12 weeks after exercise training (or conventional care)
Title
Peripheral blood gene expression
Time Frame
24 weeks after starting 12 weeks exercise training programme
Secondary Outcome Measure Information:
Title
Angina status
Time Frame
baseline
Title
Angina status
Time Frame
6wks after starting 12 week exercise programme (or conventional care)
Title
Angina status
Time Frame
12wks after starting 12 week exercise programme (or conventional care)
Title
Angina Status
Time Frame
24wks after starting 12 week exercise programme (or conventional care)
Title
Anxiety Score
Time Frame
baseline
Title
Anxiety Score
Time Frame
6wks after starting 12 week exercise programme (or conventional care)
Title
Anxiety Score
Time Frame
12wks after starting 12 week exercise programme (or conventional care)
Title
Anxiety Score
Time Frame
24wks after starting 12 week exercise programme (or conventional care)
Title
Depression Score
Time Frame
6wks after starting 12 week exercise programme (or conventional care)
Title
Depression Score
Time Frame
baseline
Title
Depression Score
Time Frame
12wks after starting 12 week exercise programme (or conventional care)
Title
Depression Score
Time Frame
24wks after starting 12 week exercise programme (or conventional care)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
NIHR Cardiovascular Biomedical Research Unit
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20955605
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.
Results Reference
derived

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The Effect of Exercise on Peripheral Blood Gene Expression in Angina

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