Effect of 3 Years of Exercise on Development of Atrial Fibrillation
This study is currently recruiting participants.
Verified September 2012 by Norwegian University of Science and Technology
Sponsor:
Norwegian University of Science and Technology
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01680302
First received: September 4, 2012
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised do moderate intensity, high intensity 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.
| Condition | Intervention |
|---|---|
|
Atrial Fibrillation |
Behavioral: High intensity exercise Behavioral: Moderate intensity exercise Behavioral: Control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effect of 3 Years of Exercise on Development of Atrial Fibrillation - A "Generation 100" Substudy |
Resource links provided by NLM:
Further study details as provided by Norwegian University of Science and Technology:
Primary Outcome Measures:
- Number of persons who develop atrial fibrillation during the 3 year intervention period [ Time Frame: 3 years ] [ Designated as safety issue: No ]People who already have the diagnosis before randomisation will not be counted.
Secondary Outcome Measures:
- Number of persons who develop atrial fibrillation during the 6 years after randomisation [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2025 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High intensity exercise
High intensity exercise(Borg 16) in intervals.
|
Behavioral: High intensity exercise |
|
Experimental: Moderate intensity exercise
Moderate intensity exercise 3 times a week.
|
Behavioral: Moderate intensity exercise |
|
Experimental: Control group
Exercise on their own. Follow current guidelines.
|
Behavioral: Control
Advised to follow current guidelines for physical activity, but exercise on their own.
|
Eligibility| Ages Eligible for Study: | 70 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Participating in the "Generation 100" study
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680302
Contacts
| Contact: Vegard Malmo | 004772829756 | vegard.malmo@ntnu.no |
Locations
| Norway | |
| Norwegian University of Science and Technology | Recruiting |
| Trondheim, Norway, 7491 | |
| Sub-Investigator: Vegard Malmo | |
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
| Study Chair: | Jan Paal Loennechen, PhD | St. Olavs Hospital |
More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01680302 History of Changes |
| Other Study ID Numbers: | 2012/978b-2 |
| Study First Received: | September 4, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services Norway: Directorate of Health |
Keywords provided by Norwegian University of Science and Technology:
|
Atrial fibrillation Prevention Exercise |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013