The Impact of Cardiac Rehabilitation Participation on Cardiac Syndrome X

This study has been completed.
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Prof. Peter Collins, National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00123617
First received: July 21, 2005
Last updated: April 21, 2015
Last verified: April 2015
  Purpose

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 Intervention Phase
Microvascular Angina
Procedure: Phase III group-based cardiac rehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Health anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Cardiac anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ] [ Designated as safety issue: No ]
  • Symptom severity [ Time Frame: Measured at baseline then continuously for 16 weeks ] [ Designated as safety issue: Yes ]
  • Symptom frequency [ Time Frame: Measured at baseline then continuously for 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cardiovascular risk factors [ Time Frame: Measured at baseline, 8 weeks and 16 weeks. ] [ Designated as safety issue: No ]
  • Physical ability [ Time Frame: Baseline and at 8 weeks ] [ Designated as safety issue: No ]
  • Time to pain [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 21, 2005
Last Updated: April 21, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on August 02, 2015