NCT06304363

Brief Summary

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurements and evaluations before and after a training period. The scientific purpose of this study is to investigate immediate and short-term effects of a booster-session of several Braining classes.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
24mo left

Started Jan 2028

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 1, 2028

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 23, 2024

Last Update Submit

February 4, 2026

Conditions

Psychiatric Disorder

Keywords

Psychiatric disorderPhysical Exercise

Outcome Measures

Primary Outcomes (1)

  • Anxiety Visual Analogue Scale (VAS)

    Self-rated anxiety levels on a scale from 0 to 100, where 0 is no anxiety and 100 is maximal anxiety.

    Pre- to post-exercise class, timeframe 2 hours

Secondary Outcomes (6)

  • Beck Anxiety Inventory BAI

    Pre-intervention to post-intervention, timeframe 1 week

  • Montgomery-Åsberg Depression Rating Scale MADRS

    Pre-intervention to post-intervention, timeframe 1 week

  • High sensitivity C-reactive protein hsCRP

    Pre- to post-exercise class, timeframe 2 hours

  • Brain-derived neurotrophic factor BDNF

    Pre- to post-exercise class, timeframe 2 hours

  • Telomerase activity

    Pre- to post-exercise class, timeframe 2 hours

  • +1 more secondary outcomes

Study Arms (1)

Physical activity

EXPERIMENTAL

Patients are encouraged to participate in physical exercise at the psychiatric unit

Behavioral: Braining

Interventions

BrainingBEHAVIORAL

"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 moderate to vigorous aerobic 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.

Physical activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Included in the retrospective study Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety and has given informed consent to participation in a Braining booster session.

You may not qualify if:

  • Severe psychiatric disorder such as mania and psychosis
  • Medical conditions such as heart- and lung diseases where PE is contraindicated.
  • Unable to understand written and spoken Swedish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, 14186, Sweden

Location

MeSH Terms

Conditions

Mental DisordersMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Lina Martinsson

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Åsa Anger

CONTACT

+46858580445asa.susanna.anger@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

March 12, 2024

Study Start (Estimated)

January 1, 2028

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

SE(1)