Rapid-Cycle Re-Implementation of TRAining Facilities in Norway (TRAiN)
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ClinicalTrials.gov Identifier: NCT04406909 |
Recruitment Status :
Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : June 23, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Training | Other: Access to training facility | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 4000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Rapid-Cycle Re-Implementation of TRAining Facilities in Norway |
Actual Study Start Date : | May 22, 2020 |
Estimated Primary Completion Date : | May 19, 2021 |
Estimated Study Completion Date : | May 19, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Training
Access to training at membership training facility
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Other: Access to training facility
Access to training facility under national regulations for COVID control |
No Intervention: No training
No access to training at membership training facility
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- COVID-19 RNA test positivity [ Time Frame: At the end of Cycle 1 (cycle length is 14 days) ]Percentage of COVID-19 RNA positive individuals
- Hospital admission for COVID-19 [ Time Frame: 7 days after the end of Cycle 1 (cycle length is 14 days) ]Percentage of people admitted to hospital for COVID-19
- individuals with COVID-19 antibodies [ Time Frame: 14 to 20 days after the end of Cycle 1 (cycle length is 14 days) ]Percentage of individuals with COVID-19 antibodies by blood sampling
- Percentage of individuals with health care contacts [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]Percentage of people who had any contacs with primary or secondary health care services
- Need of ventilator treatment after hospital admission for COVID-19 [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]Percentage of people in need of ventilator after hosital admission for COVID-19
- ICU admission for COVID-19 [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]Percentage of people admitted to the ICU for COVID-19
- Cause-specific death [ Time Frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days) ]Percentage of people who died, with cause of death (including underlying cause of death)
- COVID-19 RNA test positivity in employees at training centres [ Time Frame: At the end of Cycle 1 (cycle length is 14 days) ]Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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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
Exclusion Criteria:
- COVId-19 related comorbidity
- Age below 18 years or above 64 years

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406909
Norway | |
SATS Training | |
Oslo, Norway, 0218 |
Principal Investigator: | Magnus Løberg, MD PhD | University of Oslo | |
Principal Investigator: | Mette Kalager, MD PhD | University of Oslo |
Responsible Party: | Michael Bretthauer, Professor, University of Oslo |
ClinicalTrials.gov Identifier: | NCT04406909 |
Other Study ID Numbers: |
REK 143984 |
First Posted: | May 29, 2020 Key Record Dates |
Last Update Posted: | June 23, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |