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The Impact of Cardiac Rehabilitation Participation on Cardiac Syndrome X

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00123617
Recruitment Status : Completed
First Posted : July 25, 2005
Last Update Posted : April 22, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is designed to test the hypothesis that participation in a standard phase III group based cardiac rehabilitation programme will improve psychological morbidity, quality of life and cardiovascular risk factors, along with chest pain severity and frequency in women with cardiac syndrome X.

Condition or disease Intervention/treatment Phase
Microvascular Angina Procedure: Phase III group-based cardiac rehabilitation Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Cardiac Rehabilitation on Angina Frequency, Psychological Morbidity and Quality of Life in Women With Syndrome X
Study Start Date : January 2003
Primary Completion Date : May 2005
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Phase III cardiac rehabilitation
Phase III group-based cardiac rehabilitation classes, weekly
Procedure: Phase III group-based cardiac rehabilitation
Phase III group-based cardiac rehabilitation
Other Name: Cardiac rehab
No Intervention: Monitoring
Normal daily living, no extra visits to study centre


Outcome Measures

Primary Outcome Measures :
  1. Anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  2. Depression [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  3. Health anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  4. Cardiac anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  5. Quality of life [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  6. Symptom severity [ Time Frame: Measured at baseline then continuously for 16 weeks ]
  7. Symptom frequency [ Time Frame: Measured at baseline then continuously for 16 weeks ]

Secondary Outcome Measures :
  1. Cardiovascular risk factors [ Time Frame: Measured at baseline, 8 weeks and 16 weeks. ]
  2. Physical ability [ Time Frame: Baseline and at 8 weeks ]
  3. Time to pain [ Time Frame: Baseline and 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • Aged 30 to 80 years
  • Postmenopausal > 1 year since last menstrual period
  • Angiographically normal coronary arteries
  • Positive treadmill exercise test for myocardial ischemia
  • Reported angina pectoris > 2 episodes per week
  • Diagnosis > 6 months
  • Willing to give written informed consent

Exclusion Criteria:

  • History of psychiatric illness
  • History of any other chronic illness
  • Participation in another research study within the previous 60 days
  • Suffer any physical condition for which exercise is a contra-indication.
  • Unwilling to give written informed consent
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00123617


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

Publications:

Responsible Party: Prof. Peter Collins, Professor of Clinical Cardiology, National Heart and Lung Institute
ClinicalTrials.gov Identifier: NCT00123617     History of Changes
Other Study ID Numbers: 02-239
First Posted: July 25, 2005    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Prof. Peter Collins, National Heart and Lung Institute:
Chest pain
Women
Syndrome X
Cardiac rehabilitation
Psychological morbidity
Cardiovascular risk factors