Physical InactivityNCT05111756
Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, Implementation and Health Among Staff
An observational study of Physical Inactivity and Occupational Stress, run by Region Stockholm at 1 site in Sweden.
Trial summary
Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Inactivity, Occupational Stress
- How many people
- 49 participants
- Where
- 1 siteSweden
- Study dates
- 2 Dec 2021to 13 Jan 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Staff of a psychiatric care unit
Who may be able to join
- Works at one of the relevant units regardless of occupational category, including administrative services.
- Permanent employment or fixed-term employment for at least one more year after the start of studies.
Who cannot join
- Medical conditions such as heart or lung disease, infection, abstinence where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- Full-time sick leave> 1 month during the training period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.
Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study feasibility of the intervention will be evaluated, how Braining is perceived and implemented, and effects on health and physical activity among staff. It is hypothesized that staff health and physical activity will increase after implementing Braining at the unit. Braining will be implemented at four psychiatric units in Region Stockholm, Sweden. During 6 months staff will be trained and receive implementation support. To measure feasibility the staff will answer self-rating questionnaires and be invited to a focus group interview post the implementation period. Implementation will be evaluated by ratings of compliance, the self-rating questionnaire Normalization Process Theory Measure (S-NoMAD), and focus group interviews. Health will be measured by self ratings of stress, sleep, general health, and engagement pre implementation and every month during the 6 month implementation phase. Ratings will be repeated at follow up 12 month after implementation started. Physical activity will be rated during the 6 months implementation phase using a tracker of activity and at follow up 12 month after implementation started. All staff at the units will be invited to participate in the evaluations, approximately 20 individuals per unit.
Read the detailed description
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic high performance group training session and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. Braining is unique in that it:
- Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, high endurance group training sessions
- is included in regular healthcare fee, (free of charge)
- includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve week training period
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve week training period)
- offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
In the present study focus is on the feasibility of the intervention, how Braining is perceived and implemented, and effects on health and physical activity among staff. The research questions are:
- How do staff experience Braining regarding acceptability, applicability and suitability?
- Is there a correlation between the staff's work with Braining and occupational health, measured as performed PE, perceived stress, and general health?
- Is there a correlation between the staff's work with Braining and occupational health, measured as exhaustion, sleep, sick leave, and job engagement?
- Is there a significant interaction effect between change over time in occupational health, measured with PSS-10 and GHQ, and participation in Braining sessions according to "Ratings of Braining sessions"?
- Is there a significant interaction effect between change over time on physical activity measured with Actigraph and IPAQ and participation in Braining sessions according to "Ratings of Braining sessions"?
- Is there an interaction effect between physical activity measured with Actigraph and IPAQ and occupational health measured with PSS-10 and GHQ?
- Does Braining have a specific effect for staff who during baseline rate over cut-off on GHQ and PSS-10 respectively?
- How compliant are staff to the Braining method in the sense of number completed training sessions, quality of completed sessions, compliance with the core components of the method?
- To what extent is Braining integrated into ordinary work at the unit in short (6 months) and long term (1 and 2 years)?
Braining is to be implemented at 4 psychiatric care units the upcoming years starting nov 2021. Approximately 20 personnel on each unit will be included. Planned design is a longitudinal pre-post study with four measurements during ongoing intervention (weeks 1, 4, 8 and 12) and two follow-ups (6 months and 12 months post inclusion). Improved design with three baseline observation (data points) and possible interrupted time series design, (ITSD). Relationships between the staff's work with Braining and their own occupational health are examined self-estimates, see list. Physical activity level is measured with activity tracker before training and measured throughout the 6 months and at follow-up after 12 months.
Experience of the implementation process is evaluated with S-NoMAD, which is administered at two occasions during the intervention, after completion and at follow-up after 2 years. Staff experience of working with Braining is examined with self-assessments and in focus group interviews after the end of the intervention. Staff compliance with Braining is evaluated based on a checklist where data is collected through weekly follow-ups of the work on the unit as well as observation of completed training sessions.
Data analysis Qualitative analysis: Recorded material from focus group interviews is transcribed and analyzed based on the thematic analysis method according to Braun \& Clarke et al 2006). The method aims to understand the individual's perspective in relation to a particular phenomenon and is often used as an inductive hypothesis-generating approach.
Continuous data will be analyzed using mixed effects models or t-test, nominal data analyzed mainly with chi2 test. In mixed effects models of differences between groups the interaction effect of group and time will be the central estimate.
- Conditions
- Physical Inactivity, Occupational Stress
- Keywords
- physical exercise, psychiatric staff, Occupational Stress, implementation, feasibility
- Medical subject headings
- Sedentary Behavior, Occupational Stress, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Unit A | Staff at first phase units, receiving Braining, physical exercise | |
| Unit B | Staff at second phase units, receiving Braining, physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes spent on Physical movement (high, moderate, low)
Physical exercise conducted by staff, measured by actigraph
Measured: Change from baseline to follow up observation 6 months after inclusion
Minutes spent on Physical movement self rated (high, moderate, low)
Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)
Measured: Change from baseline to follow up observation 6 months after inclusion
General health
General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress
Measured: Change from baseline to follow up observation 6 months after inclusion
Perceived stress
Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress
Measured: Change from baseline to follow up observation 6 months after inclusion
Perceived feasibility of Intervention
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Measured: 1 month after implementation start
Perceived feasibility of Intervention
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Measured: 6 months after implementation start
Acceptability of Intervention
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Measured: 1 month after implementation start
Acceptability of Intervention
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Measured: 6 months after implementation start
Intervention Appropriateness
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Measured: 1 month after implementation start
Intervention Appropriateness
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Measured: 6 months after implementation start
Compliance to intervention
Compliance to intervention measured by weekly observations and reports of performed training activities
Measured: Summary of compliance 6 months after implementation start
Normalization of intervention
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Measured: 6 months after implementation start
Normalization of intervention
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Measured: 1 year after implementation start
Normalization of intervention
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Measured: 2 years after implementation start
Qualitative interviews
Qualitative interviews concerning acceptability, feasibility, appropriateness, compliance and normalization of the intervention
Measured: After the implementation phase i.e., 6 months after implementation start
Secondary outcomes (14)
Burnout
Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms
Measured: Change from baseline to follow up observation 6 months after inclusion
Burnout
Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms
Measured: Follow up 12 months after inclusion
Sleep difficulties
Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties
Measured: Change from baseline to follow up observation 6 months after inclusion
Sleep difficulties
Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties
Measured: Follow up 12 months after inclusion
Work and illness
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Measured: Change from baseline to follow up observation 6 months after inclusion
Work and illness
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Measured: Follow up 12 months after inclusion
Engagement at work
Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement
Measured: Change from baseline to follow up observation 6 months after inclusion
Engagement at work
Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement
Measured: Follow up 12 months after inclusion
Minutes spent on Physical movement (high, moderate, low)
Physical exercise conducted by staff, measured by actigraph
Measured: Follow up observation 12 months after inclusion
Minutes spent on Physical movement (high, moderate, low)
Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)
Measured: Follow up 12 months after inclusion
General health
General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress
Measured: Follow up 12 months after inclusion
Perceived stress
Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress
Measured: Follow up 12 months after inclusion
Ratings of Braining sessions
Self constructed questions where staff rate how many Braining sessions they have attended per week.
Measured: During the period intervention start to 6 months follow up
Ratings of Braining sessions
Self constructed questions where staff rate how many Braining sessions they have attended per week.
Measured: During the period 6 months follow up to 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start2 Dec 2021
- Primary completion30 May 2025
- Study completion13 Jan 2026
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 Physical InactivityStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Lina Martinsson, PhD, Principal investigator, Region Stockholm and Karolinska institiutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111756
- Sponsor's protocol ID
- Braining - personell
- Status last verified
- Feb 2026
- First submitted
- 22 Oct 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mac R, Saliba-Gustafsson EA, Anger A, Sundberg CJ, Martinsson L, Bergstrom A, Salomonsson S. Getting psychiatry on the move-Implementation and evaluation of Braining, a structured physical exercise intervention in outpatient psychiatry: A convergent-parallel mixed methods study. PLoS One. 2026 May 21;21(5):e0348234. doi: 10.1371/journal.pone.0348234. eCollection 2026.
PubMed 42166459
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.
- ClinicalTrials.gov ID
- NCT05111756
- Acronym / sponsor ID
- Braining - personell
- Conditions
- Physical Inactivity, Occupational Stress
- Keywords
- physical exercise, psychiatric staff, Occupational Stress, implementation, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 8 Nov 2021 (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.
Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study feasibility of the intervention will be evaluated, how Braining is perceived and implemented, and effects on health and physical activity among staff. It is hypothesized that staff health and physical activity will increase after implementing Braining at the unit. Braining will be implemented at four psychiatric units in Region Stockholm, Sweden. During 6 months staff will be trained and receive implementation support. To measure feasibility the staff will answer self-rating questionnaires and be invited to a focus group interview post the implementation period. Implementation will be evaluated by ratings of compliance, the self-rating questionnaire Normalization Process Theory Measure (S-NoMAD), and focus group interviews. Health will be measured by self ratings of stress, sleep, general health, and engagement pre implementation and every month during the 6 month implementation phase. Ratings will be repeated at follow up 12 month after implementation started. Physical activity will be rated during the 6 months implementation phase using a tracker of activity and at follow up 12 month after implementation started. All staff at the units will be invited to participate in the evaluations, approximately 20 individuals per unit.
Detailed description
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic high performance group training session and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. Braining is unique in that it:
- Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, high endurance group training sessions
- is included in regular healthcare fee, (free of charge)
- includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve week training period
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve week training period)
- offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
In the present study focus is on the feasibility of the intervention, how Braining is perceived and implemented, and effects on health and physical activity among staff. The research questions are:
- How do staff experience Braining regarding acceptability, applicability and suitability?
- Is there a correlation between the staff's work with Braining and occupational health, measured as performed PE, perceived stress, and general health?
- Is there a correlation between the staff's work with Braining and occupational health, measured as exhaustion, sleep, sick leave, and job engagement?
- Is there a significant interaction effect between change over time in occupational health, measured with PSS-10 and GHQ, and participation in Braining sessions according to "Ratings of Braining sessions"?
- Is there a significant interaction effect between change over time on physical activity measured with Actigraph and IPAQ and participation in Braining sessions according to "Ratings of Braining sessions"?
- Is there an interaction effect between physical activity measured with Actigraph and IPAQ and occupational health measured with PSS-10 and GHQ?
- Does Braining have a specific effect for staff who during baseline rate over cut-off on GHQ and PSS-10 respectively?
- How compliant are staff to the Braining method in the sense of number completed training sessions, quality of completed sessions, compliance with the core components of the method?
- To what extent is Braining integrated into ordinary work at the unit in short (6 months) and long term (1 and 2 years)?
Braining is to be implemented at 4 psychiatric care units the upcoming years starting nov 2021. Approximately 20 personnel on each unit will be included. Planned design is a longitudinal pre-post study with four measurements during ongoing intervention (weeks 1, 4, 8 and 12) and two follow-ups (6 months and 12 months post inclusion). Improved design with three baseline observation (data points) and possible interrupted time series design, (ITSD). Relationships between the staff's work with Braining and their own occupational health are examined self-estimates, see list. Physical activity level is measured with activity tracker before training and measured throughout the 6 months and at follow-up after 12 months.
Experience of the implementation process is evaluated with S-NoMAD, which is administered at two occasions during the intervention, after completion and at follow-up after 2 years. Staff experience of working with Braining is examined with self-assessments and in focus group interviews after the end of the intervention. Staff compliance with Braining is evaluated based on a checklist where data is collected through weekly follow-ups of the work on the unit as well as observation of completed training sessions.
Data analysis Qualitative analysis: Recorded material from focus group interviews is transcribed and analyzed based on the thematic analysis method according to Braun \& Clarke et al 2006). The method aims to understand the individual's perspective in relation to a particular phenomenon and is often used as an inductive hypothesis-generating approach.
Continuous data will be analyzed using mixed effects models or t-test, nominal data analyzed mainly with chi2 test. In mixed effects models of differences between groups the interaction effect of group and time will be the central estimate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unit A | – | –Staff at first phase units, receiving Braining, physical exercise |
| Unit B | – | –Staff at second phase units, receiving Braining, physical exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Staff of a psychiatric care unit
Key inclusion criteria (2 listed)
- Works at one of the relevant units regardless of occupational category, including administrative services.
- Permanent employment or fixed-term employment for at least one more year after the start of studies.
Key exclusion criteria (2 listed)
- Medical conditions such as heart or lung disease, infection, abstinence where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- Full-time sick leave> 1 month during the training period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Minutes spent on Physical movement (high, moderate, low)
Time frame: Change from baseline to follow up observation 6 months after inclusion
Physical exercise conducted by staff, measured by actigraph
Minutes spent on Physical movement self rated (high, moderate, low)
Time frame: Change from baseline to follow up observation 6 months after inclusion
Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)
General health
Time frame: Change from baseline to follow up observation 6 months after inclusion
General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress
Perceived stress
Time frame: Change from baseline to follow up observation 6 months after inclusion
Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress
Perceived feasibility of Intervention
Time frame: 1 month after implementation start
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Perceived feasibility of Intervention
Time frame: 6 months after implementation start
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Acceptability of Intervention
Time frame: 1 month after implementation start
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Acceptability of Intervention
Time frame: 6 months after implementation start
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Intervention Appropriateness
Time frame: 1 month after implementation start
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Intervention Appropriateness
Time frame: 6 months after implementation start
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Compliance to intervention
Time frame: Summary of compliance 6 months after implementation start
Compliance to intervention measured by weekly observations and reports of performed training activities
Normalization of intervention
Time frame: 6 months after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Normalization of intervention
Time frame: 1 year after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Normalization of intervention
Time frame: 2 years after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Qualitative interviews
Time frame: After the implementation phase i.e., 6 months after implementation start
Qualitative interviews concerning acceptability, feasibility, appropriateness, compliance and normalization of the intervention
14 secondary outcomes
Burnout
Time frame: Change from baseline to follow up observation 6 months after inclusion
Burnout
Time frame: Follow up 12 months after inclusion
Sleep difficulties
Time frame: Change from baseline to follow up observation 6 months after inclusion
Sleep difficulties
Time frame: Follow up 12 months after inclusion
Work and illness
Time frame: Change from baseline to follow up observation 6 months after inclusion
Work and illness
Time frame: Follow up 12 months after inclusion
Engagement at work
Time frame: Change from baseline to follow up observation 6 months after inclusion
Engagement at work
Time frame: Follow up 12 months after inclusion
Minutes spent on Physical movement (high, moderate, low)
Time frame: Follow up observation 12 months after inclusion
Minutes spent on Physical movement (high, moderate, low)
Time frame: Follow up 12 months after inclusion
General health
Time frame: Follow up 12 months after inclusion
Perceived stress
Time frame: Follow up 12 months after inclusion
Ratings of Braining sessions
Time frame: During the period intervention start to 6 months follow up
Ratings of Braining sessions
Time frame: During the period 6 months follow up to 12 months follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42166459Mac R, Saliba-Gustafsson EA, Anger A, Sundberg CJ, Martinsson L, Bergstrom A, Salomonsson S. Getting psychiatry on the move-Implementation and evaluation of Braining, a structured physical exercise intervention in outpatient psychiatry: A convergent-parallel mixed methods study. PLoS One. 2026 May 21;21(5):e0348234. doi: 10.1371/journal.pone.0348234. eCollection 2026.
- Individual participant dataSharing planned: No
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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.
Lina Martinsson, PhD principal investigator
Region Stockholm and Karolinska institiutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Inactivity and Occupational Stress, run by Region Stockholm at 1 site in Sweden.
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 2 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: finished, as of the sponsor's last update on 20 Aug 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Minutes spent on Physical movement (high, moderate, low) (time frame: Change from baseline to follow up observation 6 months after inclusion). The study lists 15 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 NCT05111756, 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 20 Aug 2026.