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Cardiac Rehabilitation for the Treatment of Refractory Angina

Primary Purpose

Angina Pectoris, Coronary Disease

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
National Heart and Lung Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angina Pectoris focused on measuring Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors

Eligibility Criteria

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

Inclusion Criteria:

  • Clinically diagnosed with refractory angina > 6 months
  • Two or more episodes of angina per week
  • Males and females aged 30 - 80
  • Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above
  • Prescribed optimal medical therapy
  • AHA exercise and training guidelines classification B and C
  • Willing to give written informed consent

Exclusion Criteria:

  • History of any other chronic illness
  • AHA exercise and training guidelines classification class D
  • Suffer any physical condition for which exercise is a contra-indication
  • Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months
  • Participation in another research study within the previous 60 days
  • History of psychiatric illness
  • Unwilling to give written informed consent

Sites / Locations

  • National Heart and Lung Institute, Imperial College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cardiac rehabilitation

Monitoring

Arm Description

8-week cardiac rehabilitation programme

Carry on life as normal

Outcomes

Primary Outcome Measures

Health anxiety
Health anxiety questionnaire (HAQ)
Generalised anxiety and depression
Hospital Anxiety and Depression scale (HADS)

Secondary Outcome Measures

Systolic and diastolic blood pressure
Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
Heart rate
Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
Anthropomometry
Weight, height, waist circumference (tape measure), hip circumference (tape measure), body mass index calculated from height and weight using the following website: http://www.nhlbisupport.com/bmi/bmi-m.htm
Fasting lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Social support
Measured using the ENRICHED social support instrument (ESSI)
Angina related health beliefs
Measured using the York angina beliefs scale.
Physical activity and exercise capacity
Progressive shuttle walk test
Angina frequency and severity
Subjects completed a daily symptom monitoring diary
Quality of life
SF-36 quality of life scale
Plasma glucose
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Urea & electrolytes
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
Liver function tests
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Thyroid function tests
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Hb
Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
HbA1C (if diabetic)
Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques

Full Information

First Posted
December 12, 2006
Last Updated
April 21, 2015
Sponsor
National Heart and Lung Institute
Collaborators
British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00411359
Brief Title
Cardiac Rehabilitation for the Treatment of Refractory Angina
Official Title
Cardiac Rehabilitation for the Treatment of Refractory Angina
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Heart and Lung Institute
Collaborators
British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether cardiac rehabilitation is a successful treatment for refractory angina, in relation to improvements in cardiovascular risk factors, physical ability, symptomology, quality of life and psychological morbidity.
Detailed Description
The majority of patients presenting with angina pectoris resulting from coronary artery disease (CHD) are successfully treated with interventions including coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) and medical management. However, a growing number of patients experience persistent angina in spite of intervention and optimal medical treatment. Such patients are referred to as suffering from 'refractory angina'. Currently, cardiac rehabilitation centres are reluctant to accept patients with ongoing angina or complicated cardiovascular history, in spite of the duration or stability of the symptoms. Indeed, angina and heart failure are often used to exclude patients from cardiac rehabilitation. However, in the recent updated American Heart Association (AHA) recommendations for exercise and training, cardiac rehabilitation and supervised exercise training is recommended for patients with ongoing angina, previous history of CABG, MI, PTCA and patients with existing cardiomyopathy in order to promote a reduction in myocardial ischaemia at rest and during sub-maximal exercise, while reducing the risk for the progression of CHD. Nevertheless, studies exploring the physiological and psychological impact of routinely available CR as a stand-alone intervention among refractory angina patients have not previously been undertaken. Until such studies are performed, CR practitioners will continue to refuse to accept refractory angina patients for participation in CR. Research questions: Is an eight-week cardiac rehabilitation exercise programme an appropriate treatment option for patients with refractory angina? Does an eight-week cardiac rehabilitation exercise programme improve the physical functioning and cardiovascular health of patients with refractory angina? Is symptom severity and frequency reduced following an eight-week cardiac rehabilitation exercise programme in patients with refractory angina? Does an eight-week cardiac rehabilitation exercise programme have any impact on anxiety, depression, cardiac anxiety and quality of life in patients with refractory angina? Are any physiological or psychological effects acquired by patients with refractory angina participating in a cardiac rehabilitation exercise programme maintained at an eight-week follow-up? The study is conceived as a randomised intervention-control study of a standard, routinely available Phase III hospital-based CR program among patients with refractory angina. Patients will be randomly assigned to an eight-week CR programme based at Harefield Hospital or symptom diary monitoring control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Coronary Disease
Keywords
Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiac rehabilitation
Arm Type
Experimental
Arm Description
8-week cardiac rehabilitation programme
Arm Title
Monitoring
Arm Type
No Intervention
Arm Description
Carry on life as normal
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
Phase III cardiac rehabilitation programme
Primary Outcome Measure Information:
Title
Health anxiety
Description
Health anxiety questionnaire (HAQ)
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Generalised anxiety and depression
Description
Hospital Anxiety and Depression scale (HADS)
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Secondary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Description
Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Heart rate
Description
Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Anthropomometry
Description
Weight, height, waist circumference (tape measure), hip circumference (tape measure), body mass index calculated from height and weight using the following website: http://www.nhlbisupport.com/bmi/bmi-m.htm
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Fasting lipids
Description
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Social support
Description
Measured using the ENRICHED social support instrument (ESSI)
Time Frame
Baseline
Title
Angina related health beliefs
Description
Measured using the York angina beliefs scale.
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Physical activity and exercise capacity
Description
Progressive shuttle walk test
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Angina frequency and severity
Description
Subjects completed a daily symptom monitoring diary
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Quality of life
Description
SF-36 quality of life scale
Time Frame
Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Title
Plasma glucose
Description
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time Frame
Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Title
Urea & electrolytes
Description
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
Time Frame
Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Title
Liver function tests
Description
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time Frame
Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Title
Thyroid function tests
Description
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time Frame
Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Title
Hb
Description
Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time Frame
Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Title
HbA1C (if diabetic)
Description
Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
Time Frame
Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring

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: Clinically diagnosed with refractory angina > 6 months Two or more episodes of angina per week Males and females aged 30 - 80 Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above Prescribed optimal medical therapy AHA exercise and training guidelines classification B and C Willing to give written informed consent Exclusion Criteria: History of any other chronic illness AHA exercise and training guidelines classification class D Suffer any physical condition for which exercise is a contra-indication Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months Participation in another research study within the previous 60 days History of psychiatric illness Unwilling to give written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Collins, MA, MD, FRCP
Organizational Affiliation
National Heart and Lung Institute, Imperial College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kim Fox, MD, FRCP
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahmud Barbir, FRCP
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart and Lung Institute, Imperial College London
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
11846493
Citation
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Citation
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Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Cardiac Rehabilitation for the Treatment of Refractory Angina

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