Braining - Evaluation of Acute Effects of Physical Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Braining.
- Who it may be relevant to
- Registry conditions: Psychiatric Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
Overview
"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 achieving 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.
Interventions
- 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.
Primary outcome measures
- Anxiety Visual Analogue Scale (VAS) [Time frame: Pre- to post-exercise class, timeframe 2 hours]
Secondary outcome measures (6)
- Beck Anxiety Inventory BAI [Time frame: Pre-intervention to post-intervention, timeframe 1 week]
- Montgomery-Åsberg Depression Rating Scale MADRS [Time frame: Pre-intervention to post-intervention, timeframe 1 week]
- High sensitivity C-reactive protein hsCRP [Time frame: Pre- to post-exercise class, timeframe 2 hours]
- Brain-derived neurotrophic factor BDNF [Time frame: Pre- to post-exercise class, timeframe 2 hours]
- Telomerase activity [Time frame: Pre- to post-exercise class, timeframe 2 hours]
- Motivational factors of continued exercise [Time frame: Pre-intervention to post-intervention, timeframe 1 week]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) — Stockholm
Identifiers
NCT: NCT06304363 · Braining booster