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NCT Number: NCT06304363

Braining - Evaluation of Acute Effects of Physical Exercise

"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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, 14186, Sweden

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Braining

Behavioral

"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.

Primary outcomes

  1. Anxiety Visual Analogue Scale (VAS)

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

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

Secondary outcomes

  1. Beck Anxiety Inventory BAI

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

    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.

  2. Montgomery-Åsberg Depression Rating Scale MADRS

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

    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.

  3. High sensitivity C-reactive protein hsCRP

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

    Blood marker of inflammation and infection, mmol/L

  4. Brain-derived neurotrophic factor BDNF

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

    Stimulates and controls neurogenesis

  5. Telomerase activity

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

    Enzyme activity in blood

  6. Motivational factors of continued exercise

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

    Semi-structured interview derived from motivational interviewing

Study contacts

Contact information is provided by the study sponsor or research team.

Åsa Anger

CONTACT

[email protected]

+46858580445

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects

Important dates

Study start
2028
Primary completion
2029
Study completion
2029
First posted
Mar 12, 2024
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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