CClinicalTrials.gg
Not yet recruitingNCT06304363Updated Feb 6, 2026

Braining - Evaluation of Acute Effects of Physical Exercise

An interventional study of Braining in Psychiatric Disorder, sponsored by Region Stockholm. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Region Stockholm · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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 moderate to vigorous aerobic group training sessions 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.

In the present study, the focus is on the acute effects of a booster session of one to three Braining classes on psychiatric symptoms and biomolecular markers as well as impact on motivational factors.

Participants are recruited from the final cohort (N = 51) of the previous retrospective study, (Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety).This final cohort will be contacted to give written consent to partake in the booster session. The Braining classes each have a duration of 30 minutes and are scheduled over the course of a week.

Descriptive data on participating patients will be collected before the booster week. This will include age, gender, diagnoses, employment status. In conjunction with this, basic psychiatric and somatic examinations will be conducted.

During each Braining class, participants' activity level will be measured with a heart rate monitor to ascertain achieving moderate to vigorous intensity. Directly before and after each class, current anxiety level will be measured on a Visual Analogue Scale 0-100.

Within 30 minutes before and after one Braining class, venous blood samples (50 ml) will be taken for biomolecular markers. Blood samples include 1) inflammation markers such as high-sensitivity C-reactive protein hsCRP, 2) Brain-derived neurotrophic factor BDNF, 3) telomerase activity and 4) epigenetic markers.

Before and after the booster week, self-assessments scales for anxiety and depressive symptoms will be administered. Qualitative data on participants' experience as well as motivational factors will be collected.

02

Conditions studied

  • Psychiatric Disorder

Keywords

  • Psychiatric disorder
  • Physical Exercise
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's planned enrollment of 30 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Region Stockholm is the lead sponsor of 119 studies on the registry; 70 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Physical activity

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

    Behavioral: Braining

Interventions

  • BehavioralBraining

    "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.

06

What researchers measure

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.

    Time frame: Pre- to post-exercise class, timeframe 2 hours

Secondary outcomes

  1. Beck Anxiety Inventory BAI

    Self-report measure of anxiety during the last week. 21 items, score ranges from 0 to 63 with higher scores indicating more severe anxiety symptoms.

    Time frame: Pre-intervention to post-intervention, timeframe 1 week

  2. Montgomery-Åsberg Depression Rating Scale MADRS

    Clinician-rated scale to assess degree of depressive symptoms. 10 items. Minimum value 0 and maximum value 60, where higher values indicate more depressive symptoms.

    Time frame: Pre-intervention to post-intervention, timeframe 1 week

  3. High sensitivity C-reactive protein hsCRP

    Blood marker of inflammation and infection, mmol/L

    Time frame: Pre- to post-exercise class, timeframe 2 hours

  4. Brain-derived neurotrophic factor BDNF

    Stimulates and controls neurogenesis

    Time frame: Pre- to post-exercise class, timeframe 2 hours

  5. Telomerase activity

    Enzyme activity in blood

    Time frame: Pre- to post-exercise class, timeframe 2 hours

  6. Motivational factors of continued exercise

    Semi-structured interview derived from motivational interviewing

    Time frame: Pre-intervention to post-intervention, timeframe 1 week

07

Study locations

1 site
  • Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
    Stockholm, Stockholm County 14186, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06304363
Lead sponsor
Region Stockholm
Collaborators
Karolinska Institutet
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Jan 1, 2028 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 6, 2026

Study contacts

Åsa Anger
Contact
asa.susanna.anger@ki.se
+46858580445
Lina Martinsson
principal investigator · Karolinska Institutet

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion