Coronary Artery DiseasePhase 2NCT00363922
Rehabilitation After Coronary Bypass Grafting. Comparison of Different Types of Rehabilitation Programs
A Phase 2 study testing Rehabilitation in institution, Rehabilitation at home and Out-patient rehabilitation at the hospital in people with Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rehabilitation in institution, Rehabilitation at home and Out-patient rehabilitation at the hospital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2006to Jun 2008
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Coronary artery bypass
Who cannot join
- Significant lung disease
- Drug abuse
- Pregnancy
- Major physical impairment
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology
Trondheim, Trondheim, 7489
About this study
Official title: Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).
- Conditions
- Coronary Artery Disease
- Being tested
- Rehabilitation in institution, Rehabilitation at home, Out-patient rehabilitation at the hospital
- Keywords
- Coronary Artery Bypass [E04.100.376.719.332]
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation in institutionBehavioural
Rehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center.
Rehabilitation at homeBehavioural
Subjects get a written prescription of exercise training, diet, etc. to follow at home.
Out-patient rehabilitation at the hospitalBehavioural
This intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rehabilitation in institution Receives: Behavioral: Rehabilitation in institution |
| 2 | Active comparator | Rehabilitation at home Receives: Behavioral: Rehabilitation at home; Behavioral: Out-patient rehabilitation at the hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption
Measured: At baseline and after 6 months
Secondary outcomes (3)
Blood analyses (different markers for cardiovascular risk and endothelian function)
Measured: At baseline and after 6 months
Endothelian function (flow mediated dilatation)
Measured: At baseline and after 6 months
Quality of life (SF36 and MacNew)
Measured: At baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Responsible party
- Sponsor
- Investigators
- Trine T. Moholdt, cand.polit, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363922
- Sponsor's protocol ID
- 4.2006.2070
- Status last verified
- Sep 2015
- First submitted
- 10 Aug 2006
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Moholdt T, Bekken Vold M, Grimsmo J, Slordahl SA, Wisloff U. Home-based aerobic interval training improves peak oxygen uptake equal to residential cardiac rehabilitation: a randomized, controlled trial. PLoS One. 2012;7(7):e41199. doi: 10.1371/journal.pone.0041199. Epub 2012 Jul 18.
PubMed 22815970
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Coronary Bypass Grafting: Home Based Rehabilitation Versus Rehabilitation in Institution and Rehabilitation in Institution Versus Out-patient Rehabilitation at the Hospital
- ClinicalTrials.gov ID
- NCT00363922
- Acronym / sponsor ID
- 4.2006.2070
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass [E04.100.376.719.332]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Stiftelsen Helse og Rehabilitering
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Aug 2006 (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.
The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Rehabilitation in institutionRehabilitation in institution |
| 2 | Active comparator | Behavioral: Rehabilitation at home, Behavioral: Out-patient rehabilitation at the hospitalRehabilitation at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery bypass
Key exclusion criteria (4 listed)
- Significant lung disease
- Drug abuse
- Pregnancy
- Major physical impairment
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 |
|---|---|---|
| Rehabilitation in institutionRehabilitation in institution for four weeks. Subjects follow standard rehabilitation in the center. | Behavioural | 1 |
| Rehabilitation at homeSubjects get a written prescription of exercise training, diet, etc. to follow at home. | Behavioural | 2 |
| Out-patient rehabilitation at the hospitalThis intervention was removed. We never got time to randomize subjects into this category. We had planned to randomize patients from one hospital to either Rehabilitation in institution (rehab center) or rehabilitation at the hospital (out patient). And also patients from another hospital to either rehabilitation in institution (rehab centre) or rehabilitation at home. We have only managed to start the study in this second hospital so far (due to maternity leave and limited time to finish a PhD) | Behavioural | 2 |
Primary outcome
Maximal oxygen consumption
Time frame: At baseline and after 6 months
3 secondary outcomes
Blood analyses (different markers for cardiovascular risk and endothelian function)
Time frame: At baseline and after 6 months
Endothelian function (flow mediated dilatation)
Time frame: At baseline and after 6 months
Quality of life (SF36 and MacNew)
Time frame: At baseline and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Results publication: PubMed 22815970Moholdt T, Bekken Vold M, Grimsmo J, Slordahl SA, Wisloff U. Home-based aerobic interval training improves peak oxygen uptake equal to residential cardiac rehabilitation: a randomized, controlled trial. PLoS One. 2012;7(7):e41199. doi: 10.1371/journal.pone.0041199. Epub 2012 Jul 18.
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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.
Trine T. Moholdt, cand.polit principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rehabilitation in institution, Rehabilitation at home and Out-patient rehabilitation at the hospital in people with Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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 4 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: finished, as of the sponsor's last update on 29 Sep 2015. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal oxygen consumption (time frame: At baseline and after 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363922, which also lists 1 linked publication.
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 29 Sep 2015.