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

Study Overview
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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.

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

Conditions
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Cardiac Disease

Intervention / Treatment
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* Behavioral: High intensity interval training


Participation Criteria
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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%

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral<br>Group-based high intensity interval training and lifestyle counseling | Behavioral: High intensity interval training<br>* Group-based high-intensity aerobic interval training and lifestyle counseling<br>* Other names: The Norwegian Ullevaal model;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, cardiac rehabilitation, quality of life