Back to resultsTrial 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)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Cardiac Rehabilitation, Exercise, Heart failure, Coronary heart disease
Eligibility Criteria
Inclusion Criteria:
1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)
Exclusion Criteria:
- Care home patients.
- Serious disability incompatible with rehabilitation.
- Social circumstances incompatible with participation.
Sites / Locations
- Bispebjeg Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise intervention
Arm Description
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
Outcomes
Primary Outcome Measures
Exercise capacity
Secondary Outcome Measures
Blood pressure, cholesterol, body composition, HRQL
Full Information
NCT ID
NCT00489801
First Posted
June 20, 2007
Last Updated
November 9, 2009
Sponsor
Bispebjerg Hospital
Collaborators
Velux Fonden
1. Study Identification
Unique Protocol Identification Number
NCT00489801
Brief Title
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
Acronym
HOME-BASE
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 Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Velux Fonden
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Cardiac Rehabilitation, Exercise, Heart failure, Coronary heart disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise intervention
Arm Type
Other
Arm Description
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
Primary Outcome Measure Information:
Title
Exercise capacity
Time Frame
At baseline and after 3,6 and 12 months
Secondary Outcome Measure Information:
Title
Blood pressure, cholesterol, body composition, HRQL
Time Frame
At baseline and after 3, 6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)
Exclusion Criteria:
Care home patients.
Serious disability incompatible with rehabilitation.
Social circumstances incompatible with participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Oerkild, MD, ph.d fellow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjeg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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
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