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

Cardiac Disease Clinical Trial

— OsloHeartEx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02249260
• Other study ID #: 2011/553 (REK)
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2014
• Last updated: September 22, 2014
• Start date: March 2011
• Est. completion date: December 2020

Study information

• Verified date: September 2014
• Source: Oslo University Hospital
• Contact: Birgitta B Nilsson, PhD
• Phone: +4793210913
• Email: b.b.nilsson[@]medisin.uio.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2020
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Behavioral:
• High intensity interval training
Group-based high-intensity aerobic interval training and lifestyle counseling

Locations

Country	Name	City	State
Norway	Norwegian Sport Clinic (NIMI)	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic and diastolic Blood Pressure	Changes from baseline in systolic and diastolic blood pressure at 12 weeks	baseline, 12 weeks	No
Primary	Change in peak oxygen uptake	Change from baseline in peak oxygen uptake at 15 months	baseline, 15 months	No
Secondary	Health related quality of life	Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks	baseline, 12 weeks	No
Secondary	Peak oxygen uptake	Change from baseline in peak oxygen uptake at 12 weeks	baseline, 12 weeks	No
Secondary	Time to exhaustion	Change from baseline in "time to exhaustion" at 15 months	baseline, 15 months	No
Secondary	Time to exhaustion	Change from baseline in time to exhaustion at 12 weeks	baseline, 12 weeks	No