TrainingTRAiNNCT04406909
Rapid-Cycle Re-Implementation of TRAining Facilities in Norway
A study testing Access to training facility in people with Training, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Training
- What is being tested?
- Access to training facility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 1 siteNorway
- Study dates
- 22 May 2020to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- COVId-19 related comorbidity
- Age below 18 years or above 64 years
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Access to training facility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to training facilityOther
Access to training facility under national regulations for COVID control
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | Access to training at membership training facility Receives: Other: Access to training facility |
| No training | No intervention | No access to training at membership training facility |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 RNA test positivity
Percentage of COVID-19 RNA positive individuals
Measured: 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
Measured: 7 days after the end of Cycle 1 (cycle length is 14 days)
Secondary outcomes (6)
individuals with COVID-19 antibodies
Percentage of individuals with COVID-19 antibodies by blood sampling
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: At the end of Cycle 1 (cycle length is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start22 May 2020
- Primary completion19 May 2021 (estimated)
- Study completion19 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Department of Health and Social Affairs
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Michael Bretthauer, University of Oslo
- Investigators
- Magnus Løberg, MD PhD, Principal investigator, University of OsloMette Kalager, MD PhD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406909
- Sponsor's protocol ID
- REK 143984
- Acronym
- TRAiN
- Status last verified
- Jun 2020
- First submitted
- 13 May 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34789188
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid-Cycle Re-Implementation of TRAining Facilities in Norway
- ClinicalTrials.gov ID
- NCT04406909
- Acronym / sponsor ID
- TRAiN / REK 143984
- Conditions
- Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- Norwegian Department of Health and Social AffairsOther government
- Study start
- 22 May 2020 (actual)
- Primary completion
- 19 May 2021 (estimated)
- Study completion
- 19 May 2022 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: Access to training facilityAccess to training at membership training facility |
| No training | No intervention | –No access to training at membership training facility |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- COVId-19 related comorbidity
- Age below 18 years or above 64 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to training facilityAccess to training facility under national regulations for COVID control | Other | Training |
Primary outcome
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
6 secondary outcomes
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 health care contacts
Time frame: 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
Time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
ICU admission for COVID-19
Time frame: 7 days and 3 months after the end of Cycle 1 (cycle length is 14 days)
Cause-specific death
Time frame: 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
Time frame: At the end of Cycle 1 (cycle length is 14 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Derived from this study: PubMed 34789188Helsingen 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.
- Individual participant dataSharing planned: No
Related trials for Training
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
Not yet recruiting
Effects of Traditional and Cluster Set Resistance Training on Muscle Strength, Hypertrophy, and Power
Strength Training Adaptations
Recruiting
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
Prehabilitation, Preoperative Aerobic Training
Not yet recruiting
Eye Dominance-based Visual Training
Eye Dominance-based Visual Training, Volleyball Players
Not yet recruiting
Comparison Between Eccentric Hamstring Training and Sprint-Specific Training
Healthy Adult, Athlete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Løberg, MD PhD principal investigator
University of Oslo
Mette Kalager, MD PhD principal investigator
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to training facility in people with Training, run by Norwegian Department of Health and Social Affairs at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 RNA test positivity (time frame: At the end of Cycle 1 (cycle length is 14 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04406909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020; AzTrials last refreshed its copy on 4 Nov 2026.