Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304363
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-23
Brief Title:
Braining - Evaluation of Acute Effects of Physical Exercise
Sponsor:
Region Stockholm
Organization:
Region Stockholm
Study Overview
Official Title:
Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 AnxietyThis 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
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 AnxietyThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None