A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo

NCT ID: NCT02249260

Last Updated: 2014-09-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2020-12-31

Brief Summary

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Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.

Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.

Detailed Description

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A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.

Conditions

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Cardiac Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral

Group-based high intensity interval training and lifestyle counseling

Group Type EXPERIMENTAL

High intensity interval training

Intervention Type BEHAVIORAL

Group-based high-intensity aerobic interval training and lifestyle counseling

Interventions

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High intensity interval training

Group-based high-intensity aerobic interval training and lifestyle counseling

Intervention Type BEHAVIORAL

Other Intervention Names

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The Norwegian Ullevaal model

Eligibility Criteria

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Inclusion Criteria

* stable coronary heart disease
* valvular surgery
* refered to high-intensity exercise training from a cardiologist

Exclusion Criteria

* acute myocardial infarction within four week
* serious rhythm disturbances
* unstable angina pectoris
* known significant comorbidity
* symptomatic peripheral vascular disease
* obstructive pulmonary disease with forced expiratory vital capacity \< 60% of predicted
* left ventricular ejection fraction \< 40%
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Birgitta Blakstad Nilsson, PhD

Postdoc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgitta B Nilsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Norwegian Sport Clinic (NIMI)

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Birgitta B Nilsson, PhD

Role: CONTACT

+4793210913

Helge Grimnes, MsC

Role: CONTACT

+4723015052

Facility Contacts

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Birgitta B Nilsson, PhD

Role: primary

+47 93210913

Other Identifiers

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2011/553 (REK)

Identifier Type: -

Identifier Source: org_study_id

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