Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01246570

First received: November 16, 2010

Last updated: April 8, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2010

Last Updated Date

April 8, 2012

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Peak oxygen uptake [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Change in peak oxygen uptake [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]

In the patients allocated to the maintenance program, peak oxygen uptake will also be measured every 3rd month

Change History

Complete list of historical versions of study NCT01246570 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Myocardial infarction [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Diagnosis of myocardial infarction during the intervention period will be recorded
Hospital readmission [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
It will be recorded whether the patients is readmitted to hospital during the intervention period
Death [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Endothelial function [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded
Blood markers [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.

Original Secondary Outcome Measures ^ICMJE

Myocardial infarction [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Diagnosis of myocardial infarction during the intervention period will be recorded
Hospital readmission [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
It will be recorded whether the patients is readmitted to hospital during the intervention period
Death [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Change in endothelial function [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Flow mediated dilatation of the brachial artery, measured by ultrasound
Change in quality of life [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Mac New health related quality of life questionnaire
Changes in blood markers [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Lipoproteins, c-peptide, ferritin, glucose, hs-CRP will be analysed. Also, blood will be stored for later analyses not yet planned.
Change in physical activity [ Time Frame: 12 months after baseline ] [ Designated as safety issue: No ]
Questionnaire and physical activity sensor (armband)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

Official Title ^ICMJE

Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coronary Disease

Intervention ^ICMJE

Behavioral: Exercise training
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
Other: Control
The patients will receive the usual care provided by the hospitals and the community health services

Study Arm (s)

Experimental: Maintenance program
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.

Intervention: Behavioral: Exercise training
Active Comparator: Control
Usual care. The patients will receive the usual care provided by the hospital and community health services

Intervention: Other: Control

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01246570

Other Study ID Numbers ^ICMJE

Adherence

Has Data Monitoring Committee

Responsible Party

Norwegian University of Science and Technology

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Trine Moholdt, Phd

Norwegian University of Science and Technology

Information Provided By

Norwegian University of Science and Technology

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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