Coronary Heart DiseaseHOME-BASENCT00489801
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
A study testing Exercise in people with Coronary Heart Disease, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2007to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)
Who cannot join
- Care home patients.
- Serious disability incompatible with rehabilitation.
- Social circumstances incompatible with participation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.
Read the 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.
- Conditions
- Coronary Heart Disease
- Being tested
- Exercise
- Keywords
- Cardiac Rehabilitation, Exercise, Heart failure, Coronary heart disease
- Medical subject headings
- Coronary Disease, Motor Activity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Exercise intervention and lifestyle counseling at centre or exercise intervention at home
| Study group | Role | What they receive |
|---|---|---|
| Exercise intervention | Other | Exercise intervention and lifestyle counseling at centre or exercise intervention at home Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Measured: At baseline and after 3,6 and 12 months
Secondary outcomes (1)
Blood pressure, cholesterol, body composition, HRQL
Measured: At baseline and after 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Velux Fonden
- Investigators
- Bodil Oerkild, MD, ph.d fellow, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489801
- Sponsor's protocol ID
- KF 11 2006-4305
- Acronym
- HOME-BASE
- Status last verified
- Nov 2009
- First submitted
- 20 Jun 2007
- Last updated
- 10 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00489801
- Acronym / sponsor ID
- HOME-BASE / KF 11 2006-4305
- Conditions
- Coronary Heart Disease
- Keywords
- Cardiac Rehabilitation, Exercise, Heart failure, Coronary heart disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Velux Fonden
- Study start
- Jan 2007
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise intervention | Other | Other: ExerciseExercise intervention and lifestyle counseling at centre or exercise intervention at home |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)
Key exclusion criteria (3 listed)
- Care home patients.
- Serious disability incompatible with rehabilitation.
- Social circumstances incompatible with participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise intervention and lifestyle counseling at centre or exercise intervention at home | Other | Exercise intervention |
Primary outcome
Exercise capacity
Time frame: At baseline and after 3,6 and 12 months
1 secondary outcome
Blood pressure, cholesterol, body composition, HRQL
Time frame: At baseline and after 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bodil Oerkild, MD, ph.d fellow principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Coronary Heart Disease, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (time frame: At baseline and after 3,6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2009.