Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Primary Purpose
Coronary Disease
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise training
Control
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease focused on measuring exercise, heart, coronary disease, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Maintenance program
Control
Arm Description
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.
Usual care. The patients will receive the usual care provided by the hospital and community health services
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Myocardial infarction
Diagnosis of myocardial infarction during the intervention period will be recorded
Hospital readmission
It will be recorded whether the patients is readmitted to hospital during the intervention period
Death
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
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
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
Physical activity
Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.
Full Information
NCT ID
NCT01246570
First Posted
November 16, 2010
Last Updated
September 24, 2014
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01246570
Brief Title
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Official Title
Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
exercise, heart, coronary disease, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maintenance program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care. The patients will receive the usual care provided by the hospital and community health services
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The patients will receive the usual care provided by the hospitals and the community health services
Primary Outcome Measure Information:
Title
Peak oxygen uptake
Description
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
Time Frame
baseline and 12 months
Secondary Outcome Measure Information:
Title
Myocardial infarction
Description
Diagnosis of myocardial infarction during the intervention period will be recorded
Time Frame
baseline and 12 months
Title
Hospital readmission
Description
It will be recorded whether the patients is readmitted to hospital during the intervention period
Time Frame
baseline and 12 months
Title
Death
Time Frame
baseline and 12 months
Title
Endothelial function
Description
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
Time Frame
baseline and 12 months
Title
Quality of life
Description
Mac New health related quality of life questionnaire. Changes in quality of life from baseline to 12 months after baseline will be recorded
Time Frame
baseline and 12 months
Title
Blood markers
Description
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
Time Frame
baseline and 12 months
Title
Physical activity
Description
Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.
Time Frame
baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trine Moholdt, Phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norwegian University of Science and Technology
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25247991
Citation
Madssen E, Arbo I, Granoien 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.0107924. eCollection 2014.
Results Reference
result
Learn more about this trial
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
We'll reach out to this number within 24 hrs