Cardiac DiseaseOsloHeartExNCT02249260
A Prospective Cohort Study of Heart Patients Included in Exercise Based Rehabilitation in Oslo
A study testing High intensity interval training in people with Cardiac Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2011to Dec 2020
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable coronary heart disease
- valvular surgery
- refered to high-intensity exercise training from a cardiologist
Who cannot join
- acute myocardial infarction within four week
- serious rhythm disturbances
- unstable angina pectoris
- known significant comorbidity
- symptomatic peripheral vascular disease
- obstructive pulmonary disease with forced expiratory vital capacity < 60% of predicted
- left ventricular ejection fraction < 40%
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Norwegian Sport Clinic (NIMI)
Oslo, Oslo, 0805
Birgitta B Nilsson, PhD, +47 93210913, b.b.nilsson@medisin.uio.no
Birgitta B Nilsson, PhD
About this study
Official title: Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo
Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.
Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.
Read the detailed description
A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.
- Conditions
- Cardiac Disease
- Being tested
- High intensity interval training
- Keywords
- Exercise, cardiac rehabilitation, quality of life
- Medical subject headings
- Heart Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval trainingBehavioural
Also called The Norwegian Ullevaal model
Group-based high-intensity aerobic interval training and lifestyle counseling
| Study group | Role | What they receive |
|---|---|---|
| Behavioral | Experimental | Group-based high intensity interval training and lifestyle counseling Receives: Behavioral: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake
Change from baseline in peak oxygen uptake at 15 months
Measured: baseline, 15 months
Secondary outcomes (4)
Health related quality of life
Changes from baseline in quality of life (COOP/WONCA and SF-36) at 12 weeks
Measured: baseline, 12 weeks
Peak oxygen uptake
Change from baseline in peak oxygen uptake at 12 weeks
Measured: baseline, 12 weeks
Time to exhaustion
Change from baseline in "time to exhaustion" at 15 months
Measured: baseline, 15 months
Time to exhaustion
Change from baseline in time to exhaustion at 12 weeks
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMar 2011
- Primary completionAug 2015 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Birgitta Blakstad Nilsson, PhD, Oslo University Hospital
- Investigators
- Birgitta B Nilsson, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249260
- Sponsor's protocol ID
- 2011/553 (REK)
- Acronym
- OsloHeartEx
- Status last verified
- Sep 2014
- First submitted
- 26 Aug 2014
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
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
- Long-term Follow up of Exercise Based Cardiac Rehabilitation in Oslo
- ClinicalTrials.gov ID
- NCT02249260
- Acronym / sponsor ID
- OsloHeartEx / 2011/553 (REK)
- Conditions
- Cardiac Disease
- Keywords
- Exercise, cardiac rehabilitation, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Mar 2011
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Sep 2014 (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.
Outcomes evaluation is a critical component in outpatient cardiac rehabilitation. The aim of this study is to examine factors who predict long-term effects of improved peak oxygen uptake one year after participating in cardiac rehabilitation.
Secondary to evaluate the short and long-term outcome of a 12-week outpatient cardiac rehabilitation program.
Detailed description
A prospective cohort study including all cardiac patients referred for outpatient cardiac rehabilitation in a primary care clinic in Oslo. The main efficacy variable is the changes in exercise capacity (VO2peak) as a primary prognostic measure of successful rehabilitation. HRQoL are measured by self-report using the COOP/WONCA questionnaire and SF-36.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral | Experimental | Behavioral: High intensity interval trainingGroup-based high intensity interval training and lifestyle counseling |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- stable coronary heart disease
- valvular surgery
- refered to high-intensity exercise training from a cardiologist
Key exclusion criteria (7 listed)
- acute myocardial infarction within four week
- serious rhythm disturbances
- unstable angina pectoris
- known significant comorbidity
- symptomatic peripheral vascular disease
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 |
|---|---|---|
| High intensity interval trainingAlso: The Norwegian Ullevaal modelGroup-based high-intensity aerobic interval training and lifestyle counseling | Behavioural | Behavioral |
Primary outcome
Change in peak oxygen uptake
Time frame: baseline, 15 months
Change from baseline in peak oxygen uptake at 15 months
4 secondary outcomes
Health related quality of life
Time frame: baseline, 12 weeks
Peak oxygen uptake
Time frame: baseline, 12 weeks
Time to exhaustion
Time frame: baseline, 15 months
Time to exhaustion
Time frame: baseline, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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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.
Birgitta B Nilsson, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training in people with Cardiac Disease, run by Oslo University Hospital 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 3 inclusion and 7 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birgitta B Nilsson, PhD (+4793210913, b.b.nilsson@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (time frame: baseline, 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.