Physical Fitness and Brain - Interventional Study of the Importance of Physical Fitness on Symptoms of Anxiety, Cognitive Ability and Sick Leave, in Primary Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Sick leave
研究概览
简要总结
According to the Global Burden of Disease report in 2015, anxiety disorders are among the top 10 contributors to years lived with disability worldwide. There is a need for effective treatment protocols. As cardiovascular fitness has a major impact on the brain's ability to change structurally and functionally, interventions involving physical exercise might prove positive in the treatment of persons with anxiety. Yet there are few high quality clinical studies with physical exercise as an intervention for anxiety disorders.
Aims:
- To test a 12 week physical exercise intervention for persons treated for anxiety disorders within primary care. The exposure of interest is intensity of physical exercise; outcomes include anxiety symptom burden, cognitive ability and sick leave.
- To gain knowledge regarding potential mechanisms by comparing serum levels of specific hormones and cytokines (characterized and associated with brain plasticity in animal models) before and after different intensities of exercise.
Implementation:
Patients will be randomized into 3 groups: 1) Intervention I: 12 week exercise program with low-intensity fitness training 3 times per week. 2) Intervention II: 12 week exercise program with moderate to high-intensity fitness training 3 times per week. 3) Control group, who will have a physiotherapy session once and will be given general advice about physical activity. At baseline, 12 weeks and 1 year data of cardiovascular fitness, anxiety symptoms, cognitive and working ability and biomarkers will be collected.
Impact:
If physical exercise positively affects anxiety disorders it would have significance, for the patients as well as for society. In addition to increased quality of life, it may decrease future marginalization and premature death among individuals suffering from anxiety disorders. Reducing medical and sick-leave costs would also liberate health care resources to be used elsewhere in an economically strained health care system.
详细描述
Overall objective To examine whether physical exercise reduces anxiety symptoms, improves cognition and decreases need of sick leave in patients with anxiety disorders in primary care.
Background Mental illness is the most common reason for unemployment in people of working age and this is a growing patient group in Swedish primary care today. A survey by the European Commission showed that 17% of the Swedish population had sought help over the past year for psychiatric problems. These figures are above average for European countries and are increasing. Sweden's costs for mental illness is around MSEK 70,000 annually - an increase of MSEK 20,000 over ten years - and the proportion of sick leave days due to a psychiatric diagnosis is currently 40%. Mental illness reduces quality of life substantially. For example, 18-year-olds with anxiety disorders have increased risk of future marginalization and have a two-fold increase in mortality not only due to suicide but several different death causes, emphasizing the importance of finding effective treatment strategies.
The ability of the adult brain to change both structurally and functionally is called brain plasticity. Both in humans and in animal models physical exercise has a major impact on brain plasticity. Physical exercise can increase neurogenesis and improve memory functions in rats, and circulating insulin-like growth factor I (IGF-I) can promote this effect. Brain-derived neurotrophic factor (BDNF), and vascular endothelial growth factor (VEGF) are also involved. In addition, there is evidence that physical activity modifies neuronal activity, increases the formation of synapses, and reduces inflammation markers, which may be correlated with neuroprotection.
The investigators have previously demonstrated an association between physical fitness and anxiety disorders, suggesting positive preventive benefits of physical exercise. The beneficial effects of exercise interventions have to date mainly been demonstrated in persons with depression.
The specific aims of this project are:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Panic syndrome (F41.0)
- •Generalized anxiety (F41.1)
- •Mixed anxiety- and depression conditions (F41.2 and F41.3)
- •Anxiety UNS (F41.9)
排除标准
- •Physical difficulties in performing a physical exercise program
- •Pathological ECG
- •Previous psychiatric illnesses
- •Ongoing abuse
- •Increased risk of suicide as determined by the GP
- •Pregnant women
- •Physical activity level at baseline exceeding one exercise occasion per week.
- •Ongoing psychotherapy
结局指标
主要结局
Sick leave
时间窗: 1 year after baseline
Questionnaire
Anxiety symptom burden
时间窗: 1 year after baseline
Established psychiatric self-assessment scales: BAI
Cognitive ability
时间窗: 1 year after baseline
Test Design Fluency, which is part of the D-Kefs battery of tests
Biomarkers in serum
时间窗: 1 year after baseline
S-IGF-I
次要结局
未报告次要终点