Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 208
- 试验地点
- 10
- 主要终点
- Physical activity
研究概览
简要总结
The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise.
The main questions are:
- does Braining lead to increased physical exercise compared to structured advice on physical exercise?
- what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise?
The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements.
The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.
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. Braining is unique in that it:
- Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, moderate to vigorous aerobic group training sessions
- is included in regular healthcare fee, (free of charge)
- includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve-week exercise intervention
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)
- offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
This study will be a multi-center study performed at 5 psychiatric outpatient units in Region Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active in accordance with WHO recommendations will be invited to participate in the study.
The research questions are:
- Does Braining increase the amount of completed physical training (PT) compared to structured advice on physical exercise (advice on PT according to guidelines)?
- What effect does Braining have on the mental and physical health, quality of life and functional level of participating patients compared to structured advice on physical exercise? Examined from the following points of view:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Intervention will be blinded to investigators during analysis of primary outcomes.
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
- •Patient at one of the psychiatric units
排除标准
- •Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
- •Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.
- •Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- •Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
- •Mental disability which means that you can not participate in group training.
- •Difficulty speaking or understanding the Swedish language.
- •Ongoing heavy substance use.
结局指标
主要结局
Physical activity
时间窗: Change from Pre intervention start to 12 weeks post intervention start
Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as \>100 steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) \> 125 SPM with ActivPAL.
Physical activity
时间窗: Change from Pre intervention start to 12 weeks post intervention start
Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as \>100 steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) \> 125 SPM with ActivPAL.
Patient Health Questionnaire 9 (PHQ-9)
时间窗: Change from Pre intervention start to 12 weeks post intervention start
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
次要结局
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Change from Pre intervention start to 12 months post intervention start)
- Insomnia Severity Index (ISI)(Change from Pre intervention start to 12 months post intervention start)
- The Work and Social Adjustment Scale (WSAS)(Change from Pre intervention start to 12 months post intervention start)
- EUROQOL 5 dimensions (EQ5D)(Change from Pre intervention start to 12 months post intervention start)
- Quality Adjusted Life Years (QALY)(Change from 12-0 months pre intervention to 0-12 months post intervention)
- Time Line follow back (TLFB)(Change from Pre intervention start to 12 months post intervention start.)
- Physical activity(Change from Pre intervention start to 12 months post intervention start)
- Patient Health Questionnaire 9 (PHQ-9)(Change from Pre intervention start to 12 months post intervention start)
- The incremental cost-effectiveness (ICER)(Change from 12-0 months pre intervention to 0-12 months post intervention)
- Blood pressure(Change from Pre intervention start to 12 months post intervention start)
- Body mass index (BMI)(Change from Pre intervention start to 12 months post intervention start)
- Waist circumference(Change from Pre intervention start to 12 months post intervention start)
- Heart rate (HR)(Change from Pre intervention start to 12 months post intervention start)
- fasting blood sugar (FBS)(Change from Pre intervention start to 12 months post intervention start)
- Hemoglobin A1c (HbA1c)(Change from Pre intervention start to 12 months post intervention start)
- Blood lipids(Change from Pre intervention start to 12 months post intervention start)
- Sensitive C-reactive protein (CRP)(Change from Pre intervention start to 12 months post intervention start)
- Negative effects(12 weeks post inclusion)
- The Client Satisfaction Questionnaire-8 (CSQ-8)(12 weeks post inclusion)
- The Credibility/Expectancy Questionnaire (CEQ)(2 weeks post inclusion)
- Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)(Change from Pre intervention start to 12 months post intervention start)
- The Alcohol Use Disorders Identification Test (Audit - C)(Change from Pre intervention start to 12 months post intervention start.)
- Physical activity(Change from pre intervention start to 12 months past intervention start.)
- Self reported physical activity(Change from Pre intervention start to 12 months post intervention start)
- Patient Health Questionnaire 9 (PHQ-9)(Change from Pre intervention start to 12 months post intervention start)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Change from Pre intervention start to 12 months post intervention start)
- Insomnia Severity Index (ISI)(Change from Pre intervention start to 12 months post intervention start)
- The Work and Social Adjustment Scale (WSAS)(Change from Pre intervention start to 12 months post intervention start)
- EUROQOL 5 dimensions (EQ5D)(Change from Pre intervention start to 12 months post intervention start)
- Quality Adjusted Life Years (QALY)(Change from 12-0 months pre intervention to 0-12 months post intervention)
- The incremental cost-effectiveness (ICER)(Change from 12-0 months pre intervention to 0-12 months post intervention)
- Blood pressure(Change from Pre intervention start to 12 months post intervention start)
- Body mass index (BMI)(Change from Pre intervention start to 12 months post intervention start)
- Waist circumference(Change from Pre intervention start to 12 months post intervention start)
- Heart rate (HR)(Change from Pre intervention start to 12 months post intervention start)
- fasting blood sugar (FBS)(Change from Pre intervention start to 12 months post intervention start)
- Hemoglobin A1c (HbA1c)(Change from Pre intervention start to 12 months post intervention start)
- Blood lipids(Change from Pre intervention start to 12 months post intervention start)
- Sensitive C-reactive protein (CRP)(Change from Pre intervention start to 12 months post intervention start)
- Complete blood count(Change from Pre intervention start to 12 months post intervention start)
- Negative effects(12 weeks post inclusion)
- The Client Satisfaction Questionnaire-8 (CSQ-8)(12 weeks post inclusion)
- The Credibility/Expectancy Questionnaire (CEQ)(2 weeks post inclusion)
- Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)(Change from Pre intervention start to 12 months post intervention start)
- Time Line follow back (TLFB)(Change from Pre intervention start to 12 months post intervention start.)
- The Alcohol Use Disorders Identification Test (Audit - C)(Change from Pre intervention start to 12 months post intervention start.)
- Physical Activity(Change from Pre intervention start to 6 months post intervention start.)