NCT01680302

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,567

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
0mo left

Started Sep 2012

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

10.8 years

First QC Date

September 4, 2012

Last Update Submit

September 16, 2022

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationPreventionExercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (1)

  • Number of persons who develop atrial fibrillation during the 6 years after randomisation

    6 years

Study Arms (3)

High intensity exercise

EXPERIMENTAL

High intensity exercise(Borg 16) in intervals.

Behavioral: High intensity exercise

Moderate intensity exercise

EXPERIMENTAL

Moderate intensity exercise 3 times a week.

Behavioral: Moderate intensity exercise

Control group

EXPERIMENTAL

Exercise on their own. Follow current guidelines.

Behavioral: Control

Interventions

High intensity exerciseBEHAVIORAL
High intensity exercise
Moderate intensity exerciseBEHAVIORAL
Moderate intensity exercise
ControlBEHAVIORAL

Advised to follow current guidelines for physical activity, but exercise on their own.

Control group

Eligibility Criteria

Age70 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Participating in the "Generation 100" study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

MeSH Terms

Conditions

Atrial FibrillationMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jan Paal Loennechen, PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2023

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2022

Record last verified: 2022-09

Locations

NO(1)