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

Not Applicable

• Conditions: Cardiac Disease
• Interventions: Behavioral: High intensity interval training

• Registration Number: NCT02249260
• Lead Sponsor: Oslo University Hospital

Brief 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2014-08-26
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-22
• Last Update Submitted: 2014-09-22
• Study First Posted: 2014-09-25
• Last Update Posted: 2014-09-25
• Primary Completion: 2015-08
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioral	High intensity interval training	Group-based high intensity interval training and lifestyle counseling

Primary Outcome Measures

Name	Time	Method
Change in peak oxygen uptake	baseline, 15 months	Change from baseline in peak oxygen uptake at 15 months

Secondary Outcome Measures

Name	Time	Method
Peak oxygen uptake	baseline, 12 weeks	Change from baseline in peak oxygen uptake at 12 weeks
Health related quality of life	baseline, 12 weeks	Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks
Time to exhaustion	baseline, 12 weeks	Change from baseline in time to exhaustion at 12 weeks

Trial Locations

Locations (1)

Norwegian Sport Clinic (NIMI); 🇳🇴 Oslo, Norway