Clinical trial NCT06304363: Braining - Evaluation of Acute Effects of Physical Exercise
Official title: Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Psychiatric disorder
Physical Exercise
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2024-03-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety Visual Analogue Scale (VAS)
timeFrame: Pre- to post-exercise class, timeframe 2 hours
Secondary outcomes:
measure: Beck Anxiety Inventory BAI
timeFrame: Pre-intervention to post-intervention, timeframe 1 week
measure: Montgomery-Åsberg Depression Rating Scale MADRS
timeFrame: Pre-intervention to post-intervention, timeframe 1 week
measure: High sensitivity C-reactive protein hsCRP
timeFrame: Pre- to post-exercise class, timeframe 2 hours
measure: Brain-derived neurotrophic factor BDNF
timeFrame: Pre- to post-exercise class, timeframe 2 hours
measure: Telomerase activity
timeFrame: Pre- to post-exercise class, timeframe 2 hours
measure: Motivational factors of continued exercise
timeFrame: Pre-intervention to post-intervention, timeframe 1 week
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Study officials:
affiliation: Karolinska Institutet
name: Lina Martinsson
role: PRINCIPAL_INVESTIGATOR
References: