Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry

NCT06012149 | Active Not Recruiting

• 1 other identifier: 2020-07130
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 5

Brief Summary

The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise. The main questions are:

• does Braining lead to increased physical exercise compared to structured advice on physical exercise?
• what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise? The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements. The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.

Conditions

Mental Disorders

Keywords

physical exercise; mental disorders

Outcome Measures

Primary Outcomes (2)

• Physical activity

  Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as \>100 steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) \> 125 SPM with ActivPAL.

  Change from Pre intervention start to 12 weeks post intervention start

• Patient Health Questionnaire 9 (PHQ-9)

  Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.

  Change from Pre intervention start to 12 weeks post intervention start

Secondary Outcomes (63)

• Physical activity

  Change from Pre intervention start to 6 months post intervention start

• Physical activity

  Change from Pre intervention start to 12 months post intervention start

• Self reported physical activity

  Change from Pre intervention start to 12 weeks post intervention start

• Self reported physical activity

  Change from Pre intervention start to 6 months post intervention start

• Self reported physical activity

  Change from Pre intervention start to 12 months post intervention start

Study Arms (2)

Braining

EXPERIMENTAL

A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.

Behavioral: Braining

Structured advice on physical activity

ACTIVE COMPARATOR

Health interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting.

Behavioral: Structured advice on physical activity

Interventions

Braining BEHAVIORAL

A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.

Braining

Structured advice on physical activity BEHAVIORAL

A 12 week program where participants are encouraged to engage in physical exercise

Also known as: Advice on physical activity

Structured advice on physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at one of the psychiatric units

You may not qualify if:

• Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
• Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.
• Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
• Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
• Mental disability which means that you can not participate in group training.
• Difficulty speaking or understanding the Swedish language.
• Ongoing heavy substance use.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (5)

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, 14186, Sweden

Location

Region Stockholm, Psykiatri Nordväst och Beroendecentrum, mottagningar Väsby

Upplands Vasby, Stockholm County, Sweden

Location

Region Stockholm, Beroendecentrum, Magnus Huss

Stockholm, Sweden

Location

Region Stockholm, Liljeholmsberget

Stockholm, Sweden

Location

Region Stockholm, Psykiatri Södra, Andreashuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Intervention will be blinded to investigators during analysis of primary outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized controlled superiority trial evaluating if the new method Braining is superior to structured advice on physical activity, concerning increasing physical activity. The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 25, 2023
• Study Start: September 27, 2023
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)