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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06304363
Other study ID # Braining booster
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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