Rapid-Cycle Re-Implementation of TRAining Facilities in Norway (TRAiN)

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.

Study Overview

• Status: Unknown
• Conditions: Training
• Intervention / Treatment: Other: Access to training facility

• Study Type: Interventional
• Enrollment (Actual): 4000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0218
    • SATS Training

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training; Access to training at membership training facility	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
individuals with COVID-19 antibodies	Percentage of individuals with COVID-19 antibodies by blood sampling	14 to 20 days after the end of Cycle 1 (cycle length is 14 days)
Percentage of individuals with health care contacts	Percentage of people who had any contacs with primary or secondary health care services	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	Percentage of people in need of ventilator after hosital 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	Percentage of people admitted to the ICU for COVID-19	7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
Cause-specific death	Percentage of people who died, with cause of death (including underlying cause of death)	7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
COVID-19 RNA test positivity in employees at training centres	Percentage of COVID-19 RNA positive employees who worked at the training centres during the intervention	At the end of Cycle 1 (cycle length is 14 days)

Collaborators and Investigators

• Sponsor: Norwegian Department of Health and Social Affairs
• Investigators: Principal Investigator: Magnus Løberg, MD PhD, University of Oslo; Principal Investigator: Mette Kalager, MD PhD, University of Oslo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2020
• Primary Completion (Anticipated): May 19, 2021
• Study Completion (Anticipated): May 19, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 21, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: REK 143984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No