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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Bispebjerg Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Velux Fonden
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00489801
First received: June 20, 2007
Last updated: November 9, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention
Coronary Heart Disease
 Other: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: At baseline and after 3,6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure, cholesterol, body composition, HRQL [ Time Frame: At baseline and after 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: January 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489801

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

No publications provided

Responsible Party: Bispebjerg University Hospital
ClinicalTrials.gov Identifier: NCT00489801     History of Changes
Other Study ID Numbers: KF 11 2006-4305
Study First Received: June 20, 2007
Last Updated: November 9, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on May 23, 2013