Braining - Evaluation of Acute Effects of Physical Exercise

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304363
• Other study ID #: Braining booster
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Region Stockholm
• Contact: Åsa Anger
• Phone: +46858580445
• Email: asa.susanna.anger[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 achieveing 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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.

Locations

Country	Name	City	State
Sweden	Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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