Cardiovascular DiseasesNCT02228603
Exercise as a Life-long Medicine in Patients With Coronary Artery Disease
A study testing high-intensity exercise training and web-based follow-up program in people with Cardiovascular Diseases and Myocardial Infarction, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Angina (Stable)
- What is being tested?
- high-intensity exercise training and web-based follow-up program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2014to 1 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- myocardial infarction, stable angina, heart surgery
- finished phase 2 cardiac rehabilitation
- clinically stable
- able to communicate in Norwegian
- able to do a maximal treadmill test
Who cannot join
- unstable angina
- serious cardiac arrhythmia
- serious heart valve insufficiency
- heart failure
- any contraindication for high intensity exercise training
- participation in other exercise study
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- pregnancy
- cognitive impairment
- drug abuse
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.
The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.
- Being tested
- high-intensity exercise training, web-based follow-up program, usual care
- Keywords
- exercise therapy, rehabilitation
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity exercise trainingBehavioural
web-based follow-up programBehavioural
usual careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| high-intensity exercise | Experimental | community-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months Receives: Behavioral: high-intensity exercise training |
| web-based follow-up | Active comparator | web-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months Receives: Behavioral: web-based follow-up program |
| control | Other | control group will receive usual care: information about recommended physical activity and healthy lifestyle Receives: Behavioral: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peak oxygen uptake
measured during exercise on treadmill (MetaMax Cortex/Innocor)
Measured: 2 years
Secondary outcomes (3)
physical activity
assessed by accelerometer SenseWear Armband Pro
Measured: 2 years
quality of life
assessed by MacNew Health-related quality of life questionnaire
Measured: 2 years
depression
assessed by Hospital anxiety and depression scale (HAD)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Asbjørn Støylen, prof, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228603
- Sponsor's protocol ID
- 2014/92
- Status last verified
- Aug 2019
- First submitted
- 27 Aug 2014
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Enhance Physical Activity After Cardiac Rehabilitation? A Randomised Controlled Study Comparing Two Follow-up Training Exercise Programs
- ClinicalTrials.gov ID
- NCT02228603
- Acronym / sponsor ID
- 2014/92
- Keywords
- exercise therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Nord-Trøndelag HF
- Study start
- Aug 2014 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 29 Aug 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.
Exercise training is a core component in cardiac rehabilitation. Exercise adherence is, however, low after rehabilitation and the transition from supervised to unsupervised exercise is problematic for many patients with coronary artery disease. Therefore, it is important to provide extended services to improve exercise adherence and healthy lifestyle changes.
The aim of this study is to assess the effect of a time-limited intervention following out-patient cardiac rehabilitation on exercise adherence and cardiovascular risk reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-intensity exercise | Experimental | Behavioral: high-intensity exercise trainingcommunity-based group program: weekly supervised high-intensity exercise training during 8 weeks, followed by group counselling every third month for 12 months |
| web-based follow-up | Active comparator | Behavioral: web-based follow-up programweb-based follow-up program: home-based group will be followed up by mail and telephone calls the first 8 weeks, then every third month for 12 months |
| control | Other | Behavioral: usual carecontrol group will receive usual care: information about recommended physical activity and healthy lifestyle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- myocardial infarction, stable angina, heart surgery
- finished phase 2 cardiac rehabilitation
- clinically stable
- able to communicate in Norwegian
- able to do a maximal treadmill test
Key exclusion criteria (9 listed)
- unstable angina
- serious cardiac arrhythmia
- serious heart valve insufficiency
- heart failure
- any contraindication for high intensity exercise training
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 exercise training | Behavioural | high-intensity exercise |
| web-based follow-up program | Behavioural | web-based follow-up |
| usual care | Behavioural | control |
Primary outcome
change in peak oxygen uptake
Time frame: 2 years
measured during exercise on treadmill (MetaMax Cortex/Innocor)
3 secondary outcomes
physical activity
Time frame: 2 years
quality of life
Time frame: 2 years
depression
Time frame: 2 years
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 30 Aug 2019.
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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.
Asbjørn Støylen, prof principal investigator
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity exercise training and web-based follow-up program in people with Cardiovascular Diseases and Myocardial Infarction, run by Norwegian University of Science and Technology at 2 sites 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 5 inclusion and 9 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 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
change in peak oxygen uptake (time frame: 2 years). 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 30 Aug 2019.