Coronary DiseaseNCT01246570
Exercise Training Adherence After Cardiac Rehabilitation in Coronary Heart Disease Patients
A study testing Exercise training in people with Coronary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- coronary heart disease patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
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.
- Conditions
- Coronary Disease
- Being tested
- Exercise training, Control
- Keywords
- exercise, heart, coronary disease, rehabilitation
- Medical subject headings
- Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingBehavioural
The patients will meet for organized exercise training once monthly and also exercise testing every third month.
ControlOther
The patients will receive the usual care provided by the hospitals and the community health services
| Study group | Role | What they receive |
|---|---|---|
| Maintenance program | Experimental | 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. Receives: Behavioral: Exercise training |
| Control | Active comparator | Usual care. The patients will receive the usual care provided by the hospital and community health services Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 12 months
Secondary outcomes (7)
Myocardial infarction
Diagnosis of myocardial infarction during the intervention period will be recorded
Measured: baseline and 12 months
Hospital readmission
It will be recorded whether the patients is readmitted to hospital during the intervention period
Measured: baseline and 12 months
Death
Measured: baseline and 12 months
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
Measured: baseline and 12 months
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
Measured: baseline and 12 months
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
Measured: baseline and 12 months
Physical activity
Questionnaire and physical activity sensor (armband) will be measured at baseline and after 12 months.
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Moholdt, Phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246570
- Sponsor's protocol ID
- Adherence
- Status last verified
- Sep 2014
- First submitted
- 16 Nov 2010
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25247991
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Home-based Exercise Training Versus Usual Care After Cardiac Rehabilitation. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01246570
- Acronym / sponsor ID
- Adherence
- Conditions
- Coronary Disease
- Keywords
- exercise, heart, coronary disease, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance program | Experimental | Behavioral: Exercise trainingPatients 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 comparator | Other: ControlUsual care. The patients will receive the usual care provided by the hospital and community health services |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- coronary heart disease patients
Key exclusion criteria (6 listed)
- unstable angina pectoris
- hemodynamic significant valve disease (> New York Heart Association class II)
- pregnancy
- left ventricular ejection fraction <30%
- kidney failure (creatinin > 140)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingThe patients will meet for organized exercise training once monthly and also exercise testing every third month. | Behavioural | Maintenance program |
| ControlThe patients will receive the usual care provided by the hospitals and the community health services | Other | Control |
Primary outcome
Peak oxygen uptake
Time frame: 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
7 secondary outcomes
Myocardial infarction
Time frame: baseline and 12 months
Hospital readmission
Time frame: baseline and 12 months
Death
Time frame: baseline and 12 months
Endothelial function
Time frame: baseline and 12 months
Quality of life
Time frame: baseline and 12 months
Blood markers
Time frame: baseline and 12 months
Physical activity
Time frame: baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Results publication: PubMed 25247991Madssen 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.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trine Moholdt, Phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Coronary Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.