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临床试验/NCT01928264
NCT01928264终止不适用

Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
13
试验地点
2
主要终点
Change in the ability to work (h/d / %)

研究概览

简要总结

We will conduct a randomized control trial to investigate whether and to what extent regular and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical fitness and (physio-)psychological functions (like subjective sleep, mental toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the ability to work, in claimants for a disability pension due to psychiatric disorders, whose ability to work had recently been assessed by means of a psychiatric expert opinion. The control group is designed very similar and implies predominantly sedentary leisure time group activities (e.g. playing board games, doing handicrafts). Measures will be performed at baseline, post-test, and at follow ups three and twelve months after post-test, some variables will additionally be assessed 4-weekly during the intervention. We expect that intervention group participants will report and show, respectively, more improved physical fitness, (physio-)psychological functioning and participations skills, as well as increased ability to work, compared to the control group.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Claimants for a disability pension due to a mental disorder, whose ability to work has been recently assessed by means of a psychiatric expert opinion
  • Both genders
  • 18-55 years old
  • Clinical diagnosis of depressive disorder, somatoform disorder, anxiety disorder, personality disorder
  • Sufficient competence in understanding, speaking and reading German
  • Sufficient cognitive, emotional and social level of functioning to be able to participate in a group
  • Physical Activity Readiness Questionnaire without evidence for reduction
  • or: Physical activity readiness certificated by the general practitioner
  • Informed consent

排除标准

  • Comorbidity with a somatic disorder that limits the ability for physical exercises
  • Pregnancy
  • Ongoing disturbance of the study

结局指标

主要结局

Change in the ability to work (h/d / %)

时间窗: baseline and 15 months

次要结局

  • Change in the ability to work (h/d / %)(baseline and 12 weeks)
  • Change in participation skills (sum score)(baseline and 12 weeks)
  • Change in psychological functioning (sum scores)(baseline and 12 weeks)
  • Change in subjective sleep quality (sum score)(baseline and 4 weeks)
  • Change in Clinical Global Impression (sum score)(baseline and 12 weeks)
  • Change in Leisure-time physical activity (sum score)(baseline and 12 weeks)
  • Change in self-efficacy (sum score)(baseline and 4 weeks)
  • Change in subjectively perceived stress (sum score)(baseline and 4 weeks)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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