Braining Study - Physical Exercise in Psychiatry - Evaluation of Acute Effects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anxiety Visual Analogue Scale (VAS)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 (Behavioral)
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)