Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-22

Study Completion Date

2022-05-19

Brief Summary

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This study tests the randomized re-opening of training facilities in Norway in relation to the COVID-19 pandemic. The investigators will use the recently developed concept of rapid-cycle randomized implementation to assure fast and safe re-introduction of training facilities by randomized testing of access restriction and measure virus exposure and immunity as well as clinical disease during the intervention to enable safe and timely downgrading of COVID-19 restrictions.

Members of training facilities in Norway age 18 to 64 years without COVID-19 related comorbidity will after informed consent be randomised to either access to training or no access in a first 2-week cycle. Testing for COVID-19 and ascertainment of clinical disease will be performed after the first cycle. If there is no clinically meaningful difference between the arms, new cycles may be implemented subsequently, e.g. with less distancing restrictions or wider age groups.

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Detailed Description

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Conditions

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Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Training

Access to training at membership training facility

Group Type EXPERIMENTAL

Access to training facility

Intervention Type OTHER

Access to training facility under national regulations for COVID control

No training

No access to training at membership training facility

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Access to training facility

Access to training facility under national regulations for COVID control

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all members of participating training facilities age 18 years or older who are not at increased risk for severe COVID-19 disease (see www.fhi.no for criteria) are eligible for participation if they

* plan to use the training facility regularly during the project period
* are willing to adhere to training policies during the project
* accept assessment of project endpoints
* approve handling of data for the project