Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study

NCT ID: NCT03810599

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

870 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-09

Study Completion Date

2029-02-28

Brief Summary

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

Detailed Description

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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

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pre-post comparison.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early cardiac rehabilitation

Single Group: 5 week cardiac rehabilitation programme. Pre-post comparison.

Group Type OTHER

Early cardiac rehabilitation

Intervention Type 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.

Interventions

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Early cardiac rehabilitation

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tone M Norekvål, PhD

Role: PRINCIPAL_INVESTIGATOR

Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Tone M Norekvål, PhD

Role: CONTACT

+4799044635

Nina B Fålun, MSc

Role: CONTACT

+4790858527

Facility Contacts

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Tone M Norekvål, PhD

Role: primary

+4799044635

Related Links

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Other Identifiers

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2014/333

Identifier Type: -

Identifier Source: org_study_id

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