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

September 22, 2014 updated by: Birgitta Blakstad Nilsson, PhD, Oslo University Hospital

Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0805
        • Recruiting
        • Norwegian Sport Clinic (NIMI)
        • Contact:
        • Principal Investigator:
          • Birgitta B Nilsson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral
Group-based high intensity interval training and lifestyle counseling
Behavioral: High intensity interval training
Group-based high-intensity aerobic interval training and lifestyle counseling
Other Names:
  • The Norwegian Ullevaal model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak oxygen uptake
Time Frame: baseline, 15 months
Change from baseline in peak oxygen uptake at 15 months
baseline, 15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: baseline, 12 weeks
Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks
baseline, 12 weeks
Peak oxygen uptake
Time Frame: baseline, 12 weeks
Change from baseline in peak oxygen uptake at 12 weeks
baseline, 12 weeks
Time to exhaustion
Time Frame: baseline, 15 months
Change from baseline in "time to exhaustion" at 15 months
baseline, 15 months
Time to exhaustion
Time Frame: baseline, 12 weeks
Change from baseline in time to exhaustion at 12 weeks
baseline, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and diastolic Blood Pressure
Time Frame: baseline, 12 weeks
Changes from baseline in systolic and diastolic blood pressure at 12 weeks
baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Birgitta B Nilsson, PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

September 22, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 22, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/553 (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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