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Trial Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial (HOME-BASE)

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ClinicalTrials.gov Identifier: NCT00489801
Recruitment Status : Unknown
Verified November 2009 by Bispebjerg Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2007
Last Update Posted : November 10, 2009
Sponsor:
Collaborator:
Velux Fonden
Information provided by:
Bispebjerg Hospital

Brief Summary:
Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Other: Exercise Not Applicable

Detailed Description:
Participation in cardiac rehabilitation is known to reduce mortality and morbidity and increase health related quality of life. However, participation rate are low among elderly cardiac patients with coronary heart disease. Home-based cardiac rehabilitation could be an attractive alternative to the centre-based programmes but studies investigating the effect of these programmes are limited and even less is known about the effect among the elderly.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: RCT Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation and Usual Care in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial.
Study Start Date : January 2007
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009


Arm Intervention/treatment
Exercise intervention
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
Other: Exercise
Exercise intervention and lifestyle counseling at centre or exercise intervention at home




Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: At baseline and after 3,6 and 12 months ]

Secondary Outcome Measures :
  1. Blood pressure, cholesterol, body composition, HRQL [ Time Frame: At baseline and after 3, 6 and 12 months ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)

Exclusion Criteria:

  1. Care home patients.
  2. Serious disability incompatible with rehabilitation.
  3. Social circumstances incompatible with participation.

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): NCT00489801


Locations
Denmark
Bispebjeg Hospital
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Velux Fonden
Investigators
Principal Investigator: Bodil Oerkild, MD, ph.d fellow

Responsible Party: Bispebjerg University Hospital
ClinicalTrials.gov Identifier: NCT00489801     History of Changes
Other Study ID Numbers: KF 11 2006-4305
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Bispebjerg Hospital:
Cardiac Rehabilitation
Exercise
Heart failure
Coronary heart disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases