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NCT Number: NCT03810599

Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

An intervention study with longitudinal follow-up of patients with coronary artery disease undergoing early cardiac rehabilitation is designed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Depression Heart Diseases Mental Disorders Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Early cardiac rehabilitation

Other

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.

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 frame: Up to 10 years

    Time to combined endpoint from inclusion.

Secondary outcomes

  1. Change in Self-reported health

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    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.

  2. Change in self-reported global health

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    The VAS scale from the EQ-5D-5L assess global health. The scale goes from 0 to 100 were lower score indicates worse health.

  3. Change in post traumatic growth

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    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.

  4. Nicotine dependence

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    The Fagerström test

  5. Change in anxiety and depression

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    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).

  6. Change in physical and mental dimensions of health

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    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

  7. Change in health status following myocardial infarction

    Time frame: Immediately after the 5 week intervention, and at 9, 31, 57 and 109 weeks

    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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Acronym: BECARES

Important dates

Study start
2013
Primary completion
2019
Study completion
2029
First posted
Jan 18, 2019
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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