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
Recruitment status was Active, not recruiting
Sponsor:
Bispebjerg Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | June 20, 2007 | ||||
| Last Updated Date | November 9, 2009 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Exercise capacity [ Time Frame: At baseline and after 3,6 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00489801 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Blood pressure, cholesterol, body composition, HRQL [ Time Frame: At baseline and after 3, 6 and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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 | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Coronary Heart Disease | ||||
| Intervention ICMJE | Other: Exercise
Exercise intervention and lifestyle counseling at centre or exercise intervention at home |
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| Study Arm (s) | Exercise intervention
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
Intervention: Other: Exercise |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 115 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: 1. Event of coronary heart disease (new myocardial infarction, CABG or PCI) Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00489801 | ||||
| Other Study ID Numbers ICMJE | KF 11 2006-4305 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Bispebjerg University Hospital | ||||
| Study Sponsor ICMJE | Bispebjerg Hospital | ||||
| Collaborators ICMJE | Velux Fonden | ||||
| Investigators ICMJE |
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| Information Provided By | Bispebjerg Hospital | ||||
| Verification Date | November 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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