Coronary Artery DiseaseBECARESNCT03810599
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
A study testing Early cardiac rehabilitation in people with Coronary Artery Disease, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Early cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 870 participants
- Where
- 1 siteNorway
- Study dates
- 9 Sep 2013to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of coronary artery disease
- >=18 years of age
- Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.
Who cannot join
- Cognitive impairment
- Unstable angina pectoris
- Aortic stenosis
- Left ventricular ejection fraction <30%
- Heart failure NYHA class III-IV
- Serious arrhythmia in need of treatment
- Being on the waiting list for percutaneous coronary intervention or coronary artery bypass grafting.
Trial locations and contacts
1 site in 1 country.
About this study
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.
Read the detailed description
The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.
- Conditions
- Coronary Artery Disease
- Being tested
- Early cardiac rehabilitation
- Keywords
- Cardiac rehabilitation adherence, Patient-reported outcomes, Post-traumatic growth, Anxiety, Depression, Adherence, Lifestyle, Self-reported health
- Medical subject headings
- Coronary Artery Disease, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early cardiac rehabilitationOther
This is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks.
For additional analysis there will be a comparison group that did not receive the intervention for practical reasons.
| Study group | Role | What they receive |
|---|---|---|
| Early cardiac rehabilitation | Other | Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison. Receives: Other: Early cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
Time to combined endpoint from inclusion.
Measured: Up to 10 years
Secondary outcomes (7)
Change in Self-reported health
The EuroQol 5-dimensions-5 level questionnaire (EQ-5D-5L) is an 5 item self-report-questionnaire assessing self-reported health. The respondent rates each item on a 5-point scale ranging from 1(indicating no problem) to 5 (indicating extreme problems). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in self-reported global health
The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in post traumatic growth
The Posttraumatic Growth Inventory-Short Form (PTGI-SF) is a 10 item scale measuring post traumatic growth. The respondent rates each item on a 6-point scale ranging from 0 (I did not experience this change as a result of my crisis) to 5 (I experienced this change to a very great degree as a result of my crisis). The scale is scored by adding all the responses.Individual factors are scored by adding responses to items on each factor. Factors are indicated by the Roman numerals after each item.
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Nicotine dependence
The Fagerström test
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale where seven of the items relate to anxiety and seven relate to depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total score is 42 (21 per subscale).
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in physical and mental dimensions of health
The Short Form Health Survey (SF-12) include 12 items with 3 to 5 response levels. It generates two health indices: mental health and physical health. The score range between 0 and 100, with 100 representing the highest level of health
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in health status following myocardial infarction
The Myocardial Infarction Dimensional Assessment Scale (MIDAS) is a PRO measure developed and validated to specifically measure the health status of individuals who have suffered a myocardial infarction. It consist of 7 domains, and is a 35 item scale where respondents rate each item on a 5-point scale ranging from 1 (never) to 5 (always). The function of the MIDAS is to indicate the extent of ill health in each of the seven domains assessed, therefore each dimension is scored separately using a simple scoring methodology.
Measured: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start9 Sep 2013
- Primary completion27 Jun 2019
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post comparison.
- Masking
- None (open label)
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tone M Norekvål, PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810599
- Sponsor's protocol ID
- 2014/333
- Acronym
- BECARES
- Status last verified
- Jun 2026
- First submitted
- 21 Dec 2018
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
- ClinicalTrials.gov ID
- NCT03810599
- Acronym / sponsor ID
- BECARES / 2014/333
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac rehabilitation adherence, Patient-reported outcomes, Post-traumatic growth, Anxiety, Depression, Adherence, Lifestyle, Self-reported health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Jan 2019 (actual)
- 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.
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.
Detailed description
The main objective of the study is to investigate patient-reported outcomes, their relation to clinical characteristics of the patients and the potential to predict health outcomes and adverse events in coronary artery disease patients participating in an early cardiac rehabilitation programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post comparison.
| Arm | Type | Receives |
|---|---|---|
| Early cardiac rehabilitation | Other | Other: Early cardiac rehabilitationSingle Group: 5 week cardiac rehabilitation programme. Pre-post comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of coronary artery disease
- >=18 years of age
- Has performed a negative exercise test (bike or treadmill) and thereby able to participate in exercise training.
Key exclusion criteria (7 listed)
- Cognitive impairment
- Unstable angina pectoris
- Aortic stenosis
- Left ventricular ejection fraction <30%
- Heart failure NYHA class III-IV
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 |
|---|---|---|
| Early cardiac rehabilitationThis is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks. For additional analysis there will be a comparison group that did not receive the intervention for practical reasons. | Other | Early cardiac rehabilitation |
Primary outcome
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke).
Time frame: Up to 10 years
Time to combined endpoint from inclusion.
7 secondary outcomes
Change in Self-reported health
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in self-reported global health
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in post traumatic growth
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Nicotine dependence
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in anxiety and depression
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in physical and mental dimensions of health
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in health status following myocardial infarction
Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tone M Norekvål, PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early cardiac rehabilitation in people with Coronary Artery Disease, run by Haukeland University Hospital 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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Time to composite of total mortality, and hospitalization for heart failure and atherothrombotic disease (including non-fatal MI, unstable angina and stroke). (time frame: Up to 10 years). 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 23 Jun 2026.