Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedSeptember 25, 2014
September 1, 2014
2.4 years
November 16, 2010
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
Myocardial infarction
baseline and 12 months
Hospital readmission
baseline and 12 months
Death
baseline and 12 months
Endothelial function
baseline and 12 months
Quality of life
baseline and 12 months
- +2 more secondary outcomes
Study Arms (2)
Maintenance program
EXPERIMENTALPatients 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
ACTIVE COMPARATORUsual care. The patients will receive the usual care provided by the hospital and community health services
Interventions
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
The patients will receive the usual care provided by the hospitals and the community health services
Eligibility Criteria
You may qualify if:
- coronary heart disease patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norwegian University of Science and Technology
Trondheim, Norway
Related Publications (1)
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.
PMID: 25247991RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trine Moholdt, Phd
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2010
First Posted
November 23, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2013
Study Completion
January 1, 2014
Last Updated
September 25, 2014
Record last verified: 2014-09