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Braining - Evaluation of Acute Effects of Physical Exercise

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06304363
Enrollment
30
Registered
2024-03-12
Start date
2028-01-01
Completion date
2029-12-31
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychiatric Disorder

Keywords

Psychiatric disorder, Physical Exercise

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.

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.

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.

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV
Karolinska Institutet
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety Visual Analogue Scale (VAS)Pre- to post-exercise class, timeframe 2 hoursSelf-rated anxiety levels on a scale from 0 to 100, where 0 is no anxiety and 100 is maximal anxiety.

Secondary

MeasureTime frameDescription
Beck Anxiety Inventory BAIPre-intervention to post-intervention, timeframe 1 weekSelf-report measure of anxiety during the last week. 21 items, score ranges from 0 to 63 with higher scores indicating more severe anxiety symptoms.
Montgomery-Åsberg Depression Rating Scale MADRSPre-intervention to post-intervention, timeframe 1 weekClinician-rated scale to assess degree of depressive symptoms. 10 items. Minimum value 0 and maximum value 60, where higher values indicate more depressive symptoms.
High sensitivity C-reactive protein hsCRPPre- to post-exercise class, timeframe 2 hoursBlood marker of inflammation and infection, mmol/L
Brain-derived neurotrophic factor BDNFPre- to post-exercise class, timeframe 2 hoursStimulates and controls neurogenesis
Telomerase activityPre- to post-exercise class, timeframe 2 hoursEnzyme activity in blood
Motivational factors of continued exercisePre-intervention to post-intervention, timeframe 1 weekSemi-structured interview derived from motivational interviewing

Countries

Sweden

Contacts

CONTACTÅsa Anger
asa.susanna.anger@ki.se+46858580445
PRINCIPAL_INVESTIGATORLina Martinsson

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026