Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

Not Applicable

Completed

• Conditions: Coronary Disease
• Interventions: Behavioral: Exercise training; Other: Control

• Registration Number: NCT01246570
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

It is known that organized cardiac rehabilitation is effective in improving exercise capacity in coronary heart disease patients. Less is known about the long-term results after cardiac rehabilitation. Earlier studies have shown that many patients quit exercising when no longer attending formal rehabilitation. The investigators wish to investigate the effect of a maintenance program after ending a rehabilitation program, and to compare this to usual care. The investigators hypothesis is that the maintenance program will result in higher exercise capacity and more physical activity compared to usual care.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-16
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2013-04
• Study Completion: 2014-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• coronary heart disease patients

Exclusion Criteria

• unstable angina pectoris
• hemodynamic significant valve disease (> New York Heart Association class II)
• pregnancy
• left ventricular ejection fraction <30%
• kidney failure (creatinin > 140)
• uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maintenance program	Exercise training	Patients will attend a "motivational exercise session" once monthly. They will also be tested (exercise test with measurement of peak oxygen uptake) every third months.
Control	Control	Usual care. The patients will receive the usual care provided by the hospital and community health services

Primary Outcome Measures

Name	Time	Method
Peak oxygen uptake	baseline and 12 months	The change in peak oxygen uptake from baseline to 12 months after baseline. In the intervention group, the peak oxygen uptake will be measured also every 3 months during the intervention period, and this will be reported

Secondary Outcome Measures

Name	Time	Method
Death	baseline and 12 months
Endothelial function	baseline and 12 months	Flow mediated dilatation of the brachial artery, measured by ultrasound. Changes in flow-mediated dilatation from baseline to 12 months after baseline will be recorded
Quality of life	baseline and 12 months	Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded
Myocardial infarction	baseline and 12 months	Diagnosis of myocardial infarction during the intervention period will be recorded
Hospital readmission	baseline and 12 months	It will be recorded whether the patients is readmitted to hospital during the intervention period
Blood markers	baseline and 12 months	Lipoproteins, c-peptide, ferritin, glucose, high sensitive c-reactive protein will be analysed. Also, blood will be stored for later analyses not yet planned. Changes in markers from baseline to 12 months after baseline will be recorded
Physical activity	baseline and 12 months	Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.

Trial Locations

Locations (1)

Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway