Braining - Evaluation of Acute Effects of Physical Exercise
- Conditions
- Psychiatric Disorder
- Interventions
- Behavioral: Braining
- Registration Number
- NCT06304363
- Lead Sponsor
- Region Stockholm
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Physical activity Braining Patients are encouraged to participate in physical exercise at the psychiatric unit
- Primary Outcome Measures
Name Time Method Anxiety Visual Analogue Scale (VAS) Pre- to post-exercise class, timeframe 2 hours Self-rated anxiety levels on a scale from 0 to 100, where 0 is no anxiety and 100 is maximal anxiety.
- Secondary Outcome Measures
Name Time Method Beck Anxiety Inventory BAI Pre-intervention to post-intervention, timeframe 1 week 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.
High sensitivity C-reactive protein hsCRP Pre- to post-exercise class, timeframe 2 hours Blood marker of inflammation and infection, mmol/L
Montgomery-Åsberg Depression Rating Scale MADRS Pre-intervention to post-intervention, timeframe 1 week 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.
Brain-derived neurotrophic factor BDNF Pre- to post-exercise class, timeframe 2 hours Stimulates and controls neurogenesis
Motivational factors of continued exercise Pre-intervention to post-intervention, timeframe 1 week Semi-structured interview derived from motivational interviewing
Telomerase activity Pre- to post-exercise class, timeframe 2 hours Enzyme activity in blood
Trial Locations
- Locations (1)
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
🇸🇪Stockholm, Sweden