Braining - Evaluation of Acute Effects of Physical Exercise

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

"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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psychiatric Disorder
• Intervention / Treatment: Behavioral: Braining

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Åsa Anger; Phone Number: +46858580445; Email: asa.susanna.anger@ki.se

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical activity; Patients are encouraged to participate in physical exercise at the psychiatric unit

Behavioral: Braining; "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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-intervention to post-intervention, timeframe 1 week
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.	Pre-intervention to post-intervention, timeframe 1 week
High sensitivity C-reactive protein hsCRP	Blood marker of inflammation and infection, mmol/L	Pre- to post-exercise class, timeframe 2 hours
Brain-derived neurotrophic factor BDNF	Stimulates and controls neurogenesis	Pre- to post-exercise class, timeframe 2 hours
Telomerase activity	Enzyme activity in blood	Pre- to post-exercise class, timeframe 2 hours
Motivational factors of continued exercise	Semi-structured interview derived from motivational interviewing	Pre-intervention to post-intervention, timeframe 1 week

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Lina Martinsson, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Physical Exercise; Psychiatric disorder
• Additional Relevant MeSH Terms: Behavior; Mental Disorders; Motor Activity
• Other Study ID Numbers: Braining booster

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No