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Braining - Evaluation of Acute Effects of Physical Exercise

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ClinicalTrials.gov Identifier: NCT06304363
Recruitment Status : Not yet recruiting
First Posted : March 12, 2024
Last Update Posted : March 12, 2024
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Region Stockholm

Study Description
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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.


Condition or disease Intervention/treatment Phase
Psychiatric Disorder Behavioral: Braining Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
Estimated Study Start Date : September 1, 2024
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical activity
Patients are encouraged to participate in physical exercise at the psychiatric unit
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety Visual Analogue Scale (VAS) [ Time Frame: 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 :
  1. Beck Anxiety Inventory BAI [ Time Frame: 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.

  2. Montgomery-Åsberg Depression Rating Scale MADRS [ Time Frame: 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.

  3. High sensitivity C-reactive protein hsCRP [ Time Frame: Pre- to post-exercise class, timeframe 2 hours ]
    Blood marker of inflammation and infection, mmol/L

  4. Brain-derived neurotrophic factor BDNF [ Time Frame: Pre- to post-exercise class, timeframe 2 hours ]
    Stimulates and controls neurogenesis

  5. Telomerase activity [ Time Frame: Pre- to post-exercise class, timeframe 2 hours ]
    Enzyme activity in blood

  6. Motivational factors of continued exercise [ Time Frame: Pre-intervention to post-intervention, timeframe 1 week ]
    Semi-structured interview derived from motivational interviewing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06304363


Contacts
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Contact: Åsa Anger +46858580445 asa.susanna.anger@ki.se

Locations
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Sweden
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Sweden, 14186
Sponsors and Collaborators
Region Stockholm
Karolinska Institutet
Investigators
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Principal Investigator: Lina Martinsson Karolinska Institutet
More Information
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Responsible Party: Region Stockholm
ClinicalTrials.gov Identifier: NCT06304363    
Other Study ID Numbers: Braining booster
First Posted: March 12, 2024    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Stockholm:
Psychiatric disorder
Physical Exercise
Additional relevant MeSH terms:
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Mental Disorders
Problem Behavior
Behavioral Symptoms