Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246570
• Other study ID #: Adherence
• Status: Completed
• Phase: N/A
• First received: November 16, 2010
• Last updated: September 24, 2014
• Start date: November 2010
• Est. completion date: January 2014

Study information

• Verified date: September 2014
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

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

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Madssen E, Arbo I, Granøien I, Walderhaug L, Moholdt T. Peak oxygen uptake after cardiac rehabilitation: a randomized controlled trial of a 12-month maintenance program versus usual care. PLoS One. 2014 Sep 23;9(9):e107924. doi: 10.1371/journal.pone.01079 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak oxygen uptake	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	baseline and 12 months	No
Secondary	Myocardial infarction	Diagnosis of myocardial infarction during the intervention period will be recorded	baseline and 12 months	No
Secondary	Hospital readmission	It will be recorded whether the patients is readmitted to hospital during the intervention period	baseline and 12 months	No
Secondary	Death		baseline and 12 months	No
Secondary	Endothelial function	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	baseline and 12 months	No
Secondary	Quality of life	Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded	baseline and 12 months	No
Secondary	Blood markers	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	baseline and 12 months	No
Secondary	Physical activity	Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.	baseline and 12 months	No