Exercise in Anxiety and Posttraumatic Stress Disorders - a Randomized Controlled Clinical Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
研究概览
简要总结
Aim: Aerobic and resistance exercise showed anxiolytic effects in clinical populations. Climbing could further enhance self-efficacy. Aim of the study is to examine whether climbing exercise and aerobic exercise, compared to social contact control, reduces symptoms of disease in out-patients with anxiety disorder (AD) and post-traumatic stress disorder (PTSD). Further analyses are aiming to reveal differences between climbing - and aerobic exercise.
Design: Randomized controlled clinical trial Participants: Thirty out-patients diagnosed with International Classification of Disease-Version 10 (ICD-10) (F40, F41, F43.1) for AD or PTSD.
Intervention: Out-patients will be assigned randomly to a climbing exercise group (a), aerobic exercise group (Nordic walking) (b) or social contact control group (c).
Measurements: Primary outcome is symptom severity in AD or Post Traumatic Stress Disorders. Further secondary outcomes are evaluated by psychological questionnaires assessing depression, worry symptoms, quality of life, self-efficacy and affective responses. Metabolites of neurotransmitters, immune-activation markers and anthropometric data will be additionally provided as secondary physiological outcomes.
Duration: Intervention duration is four weeks with 2 x 75 min for every group (climbing exercise, aerobic exercise, social contact control). Measurement points are set at the beginning (t1), at the end of the intervention (t2) and 3 (t3) and 6 (t4) months follow-up.
详细描述
The proposed research project is designed as a randomized controlled clinical trial with three arms. The efficacy of a climbing exercise program, an aerobic exercise program and a social contact control group on primary and secondary study outcome will be investigated (see Figure 1). Patients will be first screened by the outpatient-unit of the Department of Psychosomatics at the Medical University of Innsbruck or remitted through the treating staff network community. When assessed as eligible for the study, a group of up to ten out-patients will be randomly selected and invited to an informative meeting. Patients receive study information and time tables for their group attendances. The intervention will start within the following week and will end four weeks after beginning. Follow-up assessments will take place three and six months after intervention.
In addition to the AD/PTSD symptom screening, secondary study outcomes will be assessed:
- at study inclusion (t1)
- at the end of the intervention (t2)
- three months after the intervention (t3)
- six months after the intervention (t4)
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 (Participant)
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
- •ICD-10 diagnosis of Anxiety Disorder or Post Traumatic Stress Disorder: F40, F41, F43.1;
- •age range: 18-65
- •written informed consent
- •stable medication (if needed) for at least 3 weeks
排除标准
- •acute psychosis or suicidal behaviour
- •medical contraindication to physical activity (assessed by a clinician)
- •cognitive deficits
- •problems with German language
结局指标
主要结局
Change from Baseline (t1) Symptoms of Anxiety at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
时间窗: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Beck Anxiety Inventory (BAI; Beck \& Steer, 1990) The BAI ranges from 0 and 63 points with lower points indicating less symptoms of anxiety
Change from Baseline (t1) Symptoms of Posttraumatic Stress Disorder at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)
时间窗: 1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours
Post Traumatic Stress Disorder Checklist Civil Version (PCL-5; Weathers et al., 2013) The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of PTSD The PCL-5 ranges from 0 and 80 points with lower points indicating less symptoms of Posttraumatic Stress Disorder
次要结局
- Change from Baseline (t1) Analyses of neurotransmitter metabolites at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)
- Affective Responses_d(38 minutes after beginning of intervention)
- Change from Baseline (t1) Depression at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)
- Change from Baseline (t1) Worry Symptoms at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)
- Change from Baseline (t1) Quality of Life (WHO) at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)
- Change from Baseline (t1) Self Efficacy at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)
- Affective Responses_a(1 minute before each intervention, after 38 minutes, after 75 minutes)
- Affective Responses_b(1 minute before each intervention, after 38 minutes, after 75 minutes)
- Affective Responses_c(1 minute before each intervention, after 75 minutes)
- Change from Baseline (t1) Analyses of immune-activation markers at four weeks (t2), three months after intervention (t3) and six months after intervention (t4)(1 hour before intervention, after 672 hours, after 2328 hours, after 4488 hours)