NCT00411359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

December 12, 2006

Last Update Submit

April 21, 2015

Conditions

Angina PectorisCoronary Disease

Keywords

Refractory anginaCardiac rehabilitationSymptomologyPhysical abilityExercisePsychologyQuality of lifeRisk factors

Outcome Measures

Primary Outcomes (2)

  • Health anxiety

    Health anxiety questionnaire (HAQ)

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

  • Generalised anxiety and depression

    Hospital Anxiety and Depression scale (HADS)

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

Secondary Outcomes (15)

  • Systolic and diastolic blood pressure

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

  • Heart rate

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

  • Anthropomometry

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

  • Fasting lipids

    Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)

  • Social support

    Baseline

  • +10 more secondary outcomes

Study Arms (2)

Cardiac rehabilitation

EXPERIMENTAL

8-week cardiac rehabilitation programme

Behavioral: Cardiac rehabilitation

Monitoring

NO INTERVENTION

Carry on life as normal

Interventions

Cardiac rehabilitationBEHAVIORAL

Phase III cardiac rehabilitation programme

Cardiac rehabilitation

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College London

London, SW3 6LY, United Kingdom

Location

Related Publications (16)

  • Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.

    PMID: 11846493BACKGROUND

  • DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. doi: 10.1136/hrt.2003.025031. No abstract available.

    PMID: 14729809BACKGROUND

  • Gowda RM, Khan IA, Punukollu G, Vasavada BC, Nair CK. Treatment of refractory angina pectoris. Int J Cardiol. 2005 May 11;101(1):1-7. doi: 10.1016/j.ijcard.2004.03.066.

    PMID: 15860376BACKGROUND

  • Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-105. doi: 10.1016/S0304-3959(00)00270-0.

    PMID: 10863051BACKGROUND

  • Stewart S. Refractory to medical treatment but not to nursing care: can we do more for patients with chronic angina pectoris? Eur J Cardiovasc Nurs. 2003 Sep;2(3):169-70. doi: 10.1016/S1474-5151(03)00067-7. No abstract available.

    PMID: 14622623BACKGROUND

  • Moore RK, Groves D, Bateson S, Barlow P, Hammond C, Leach AA, Chester MR. Health related quality of life of patients with refractory angina before and one year after enrolment onto a refractory angina program. Eur J Pain. 2005 Jun;9(3):305-10. doi: 10.1016/j.ejpain.2004.07.013.

    PMID: 15862480BACKGROUND

  • Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. doi: 10.1186/cvm-2-5-221.

    PMID: 11806801BACKGROUND

  • Hevey D, Brown A, Cahill A, Newton H, Kierns M, Horgan JH. Four-week multidisciplinary cardiac rehabilitation produces similar improvements in exercise capacity and quality of life to a 10-week program. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):17-21. doi: 10.1097/00008483-200301000-00004.

    PMID: 12576907BACKGROUND

  • Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0.

    PMID: 12062135BACKGROUND

  • Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation II: referral and participation. Gen Hosp Psychiatry. 2002 May-Jun;24(3):127-34. doi: 10.1016/s0163-8343(02)00179-2.

    PMID: 12062136BACKGROUND

  • Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015.

    PMID: 10204976BACKGROUND

  • Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x.

    PMID: 10894639BACKGROUND

  • Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.

    PMID: 11581152BACKGROUND

  • Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.

    PMID: 15121495BACKGROUND

  • Asbury EA, Creed F, Collins P. Distinct psychosocial differences between women with coronary heart disease and cardiac syndrome X. Eur Heart J. 2004 Oct;25(19):1695-701. doi: 10.1016/j.ehj.2004.07.035.

    PMID: 15451147BACKGROUND

  • Asbury EA, Webb CM, Probert H, Wright C, Barbir M, Fox K, Collins P. Cardiac rehabilitation to improve physical functioning in refractory angina: a pilot study. Cardiology. 2012;122(3):170-7. doi: 10.1159/000339224. Epub 2012 Jul 27.

    PMID: 22846707RESULT

MeSH Terms

Conditions

Angina PectorisCoronary DiseaseMotor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Cardiology

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 14, 2006

Study Start

December 1, 2006

Primary Completion

December 1, 2009

Study Completion

April 1, 2010

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

GB(1)