Rapid-Cycle Re-Implementation of TRAining Facilities in Norway

NCT04406909 | Unknown DMC

• 1 other identifier: REK 143984
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Training

Outcome Measures

Primary Outcomes (2)

• COVID-19 RNA test positivity

  Percentage of COVID-19 RNA positive individuals

  At the end of Cycle 1 (cycle length is 14 days)

• Hospital admission for COVID-19

  Percentage of people admitted to hospital for COVID-19

  7 days after the end of Cycle 1 (cycle length is 14 days)

Secondary Outcomes (6)

• individuals with COVID-19 antibodies

  14 to 20 days after the end of Cycle 1 (cycle length is 14 days)

• Percentage of individuals with health care contacts

  7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)

• Need of ventilator treatment after hospital admission for COVID-19

  7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)

• ICU admission for COVID-19

  7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)

• Cause-specific death

  7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)

Study Arms (2)

Training

EXPERIMENTAL

Access to training at membership training facility

Other: Access to training facility

No training

NO INTERVENTION

No access to training at membership training facility

Interventions

Access to training facility OTHER

Access to training facility under national regulations for COVID control

Training

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• COVId-19 related comorbidity
• Age below 18 years or above 64 years

Sponsors & Collaborators

• Norwegian Department of Health and Social Affairs: lead

Study Sites (1)

SATS Training

Oslo, 0218, Norway

Location

Related Publications (1)

• Helsingen LM, Loberg M, Refsum E, Gjostein DK, Wieszczy P, Olsvik O, Juul FE, Barua I, Jodal HC, Herfindal M, Mori Y, Jore S, Lund-Johansen F, Fretheim A, Bretthauer M, Kalager M; TRAiN study group. Covid-19 transmission in fitness centers in Norway - a randomized trial. BMC Public Health. 2021 Nov 16;21(1):2103. doi: 10.1186/s12889-021-12073-0.

  PMID: 34789188 DERIVED

Study Officials

• Magnus Løberg, MD PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Mette Kalager, MD PhD

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 29, 2020
• Study Start: May 22, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2022
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)