Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
BECARES
1 other identifier
interventional
870
1 country
1
Brief Summary
An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Sep 2013
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2013
CompletedFirst Submitted
Initial submission to the registry
December 21, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
ExpectedJanuary 18, 2019
November 1, 2018
5.4 years
December 21, 2018
January 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 10 years
Secondary Outcomes (7)
Change in Self-reported health
Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in self-reported global health
Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in post traumatic growth
Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Nicotine dependence
Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
Change in anxiety and depression
Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks
- +2 more secondary outcomes
Study Arms (1)
Early cardiac rehabilitation
OTHERSingle Group: 5 week cardiac rehabilitation programme. Pre-post comparison.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Haukeland University Hospital
Bergen, 5021, Norway
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tone M Norekvål, PhD
Haukeland University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2018
First Posted
January 18, 2019
Study Start
September 9, 2013
Primary Completion
February 1, 2019
Study Completion (Estimated)
February 1, 2029
Last Updated
January 18, 2019
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share