Atrial FibrillationNCT01680302
Effect of 3 Years of Exercise on Development of Atrial Fibrillation
A study testing High intensity exercise and Moderate intensity exercise in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. Read more about this study
- Who is it for?
- Ages 70 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- High intensity exercise and Moderate intensity exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,567 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2012to Jun 2026
- 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 70 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participating in the "Generation 100" study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.
- Conditions
- Atrial Fibrillation
- Being tested
- High intensity exercise, Moderate intensity exercise, Control
- Keywords
- Atrial fibrillation, Prevention, Exercise
- Medical subject headings
- Atrial Fibrillation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity exerciseBehavioural
Moderate intensity exerciseBehavioural
ControlBehavioural
Advised to follow current guidelines for physical activity, but exercise on their own.
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise | Experimental | High intensity exercise(Borg 16) in intervals. Receives: Behavioral: High intensity exercise |
| Moderate intensity exercise | Experimental | Moderate intensity exercise 3 times a week. Receives: Behavioral: Moderate intensity exercise |
| Control group | Experimental | Exercise on their own. Follow current guidelines. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of persons who develop atrial fibrillation during the 3 year intervention period
People who already have the diagnosis before randomisation will not be counted.
Measured: 3 years
Secondary outcomes (1)
Number of persons who develop atrial fibrillation during the 6 years after randomisation
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2023 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Paal Loennechen, PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680302
- Sponsor's protocol ID
- 2012/978b-2
- Status last verified
- Sep 2022
- First submitted
- 4 Sep 2012
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy
- ClinicalTrials.gov ID
- NCT01680302
- Acronym / sponsor ID
- 2012/978b-2
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Prevention, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,567 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Sep 2012 (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.
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise | Experimental | Behavioral: High intensity exerciseHigh intensity exercise(Borg 16) in intervals. |
| Moderate intensity exercise | Experimental | Behavioral: Moderate intensity exerciseModerate intensity exercise 3 times a week. |
| Control group | Experimental | Behavioral: ControlExercise on their own. Follow current guidelines. |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Participating in the "Generation 100" study
Key exclusion criteria (1 listed)
- -
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 | Behavioural | High intensity exercise |
| Moderate intensity exercise | Behavioural | Moderate intensity exercise |
| ControlAdvised to follow current guidelines for physical activity, but exercise on their own. | Behavioural | Control group |
Primary outcome
Number of persons who develop atrial fibrillation during the 3 year intervention period
Time frame: 3 years
People who already have the diagnosis before randomisation will not be counted.
1 secondary outcome
Number of persons who develop atrial fibrillation during the 6 years after randomisation
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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.
Jan Paal Loennechen, PhD study chair
St. Olavs 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 exercise and Moderate intensity exercise in people with Atrial Fibrillation, 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 1 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 19 Sep 2022. 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?
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?
Number of persons who develop atrial fibrillation during the 3 year intervention period (time frame: 3 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 19 Sep 2022.