Cardiac Rehabilitation for the Treatment of Refractory Angina

This study has been completed.
Sponsor:
Collaborators:
British Heart Foundation
Royal Brompton & Harefield NHS Foundation Trust
Information provided by:
National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00411359
First received: December 12, 2006
Last updated: July 21, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Angina Pectoris
Coronary Disease
Behavioral: Cardiac rehabilitation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Rehabilitation for the Treatment of Refractory Angina

Resource links provided by NLM:


Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:
  • Health anxiety [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Health anxiety questionnaire (HAQ)

  • Generalised anxiety and depression [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression scale (HADS)


Secondary Outcome Measures:
  • Systolic and diastolic blood pressure [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Measured after 10 minutes sitting, using automated machine (eg. Omron machine)

  • Heart rate [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse

  • Anthropomometry [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.

  • Social support [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured using the ENRICHED social support instrument (ESSI)

  • Angina related health beliefs [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Measured using the York angina beliefs scale.

  • Physical activity and exercise capacity [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Progressive shuttle walk test

  • Angina frequency and severity [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    Subjects completed a daily symptom monitoring diary

  • Quality of life [ Time Frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring) ] [ Designated as safety issue: No ]
    SF-36 quality of life scale

  • Plasma glucose [ Time Frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.

  • Urea & electrolytes [ Time Frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques

  • Liver function tests [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.

  • Thyroid function tests [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.

  • Hb [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.

  • HbA1C (if diabetic) [ Time Frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring ] [ Designated as safety issue: No ]
    Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques


Enrollment: 42
Study Start Date: December 2006
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac rehabilitation
8-week cardiac rehabilitation programme
Behavioral: Cardiac rehabilitation
Phase III cardiac rehabilitation programme
No Intervention: Monitoring
Carry on life as normal

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411359

Locations
United Kingdom
National Heart and Lung Institute, Imperial College London
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
National Heart and Lung Institute
British Heart Foundation
Royal Brompton & Harefield NHS Foundation Trust
Investigators
Principal Investigator: Peter Collins, MA, MD, FRCP National Heart and Lung Institute, Imperial College London
Principal Investigator: Kim Fox, MD, FRCP Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Mahmud Barbir, FRCP Royal Brompton & Harefield NHS Foundation Trust
  More Information

Publications:

Responsible Party: Gary Roper, Head of Regulatory Compliance, Imperial College London
ClinicalTrials.gov Identifier: NCT00411359     History of Changes
Other Study ID Numbers: 06/Q0404/77, PG/06/087/21239
Study First Received: December 12, 2006
Last Updated: July 21, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by National Heart and Lung Institute:
Refractory angina
Cardiac rehabilitation
Symptomology
Physical ability
Exercise
Psychology
Quality of life
Risk factors

Additional relevant MeSH terms:
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014