Effect of 3 Years of Exercise on Development of Atrial Fibrillation

September 16, 2022 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1567

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7491
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participating in the "Generation 100" study

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of persons who develop atrial fibrillation during the 6 years after randomisation
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Chair: Jan Paal Loennechen, PhD, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

September 4, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 7, 2012

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/978b-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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