Braining - Evaluation of Acute Effects of Physical Exercise
ConditionPsychiatric Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm
About this trial
"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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Braining
Behavioral"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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Physical activityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre- to post-exercise class, timeframe 2 hoursSecondary outcomes
1
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.
Time frame
Pre-intervention to post-intervention, timeframe 1 week2
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.
Time frame
Pre-intervention to post-intervention, timeframe 1 week3
High sensitivity C-reactive protein hsCRP
Blood marker of inflammation and infection, mmol/L
Time frame
Pre- to post-exercise class, timeframe 2 hours4
Brain-derived neurotrophic factor BDNF
Stimulates and controls neurogenesis
Time frame
Pre- to post-exercise class, timeframe 2 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Stockholm
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: