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临床试验/NCT06304363
NCT06304363
尚未招募
不适用

Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects

Region Stockholm1 个研究点 分布在 1 个国家目标入组 30 人2028年1月1日
干预措施Braining

概览

阶段
不适用
干预措施
Braining
疾病 / 适应症
Psychiatric Disorder
发起方
Region Stockholm
入组人数
30
试验地点
1
主要终点
Anxiety Visual Analogue Scale (VAS)
状态
尚未招募
最后更新
2个月前

概览

简要总结

"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.

详细描述

"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.

注册库
clinicaltrials.gov
开始日期
2028年1月1日
结束日期
2029年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Physical activity

Patients are encouraged to participate in physical exercise at the psychiatric unit

干预措施: Braining

结局指标

主要结局

Anxiety Visual Analogue Scale (VAS)

时间窗: 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.

次要结局

  • Beck Anxiety Inventory BAI(Pre-intervention to post-intervention, timeframe 1 week)
  • High sensitivity C-reactive protein hsCRP(Pre- to post-exercise class, timeframe 2 hours)
  • Montgomery-Åsberg Depression Rating Scale MADRS(Pre-intervention to post-intervention, timeframe 1 week)
  • Brain-derived neurotrophic factor BDNF(Pre- to post-exercise class, timeframe 2 hours)
  • Motivational factors of continued exercise(Pre-intervention to post-intervention, timeframe 1 week)
  • Telomerase activity(Pre- to post-exercise class, timeframe 2 hours)

研究点 (1)

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