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)

November 9, 2009 updated by: Bispebjerg Hospital

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.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Bispebjeg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity
Time Frame: At baseline and after 3,6 and 12 months
At baseline and after 3,6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure, cholesterol, body composition, HRQL
Time Frame: At baseline and after 3, 6 and 12 months
At baseline and after 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Velux Fonden

Investigators

  • Principal Investigator: Bodil Oerkild, MD, ph.d fellow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Anticipated)

July 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

June 20, 2007

First Submitted That Met QC Criteria

June 20, 2007

First Posted (Estimate)

June 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 11 2006-4305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe