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临床试验/NCT02079012
NCT02079012已完成不适用

Short- and Long-term Effects of a Walking Program ("Join the Walk?") on Physical Activity, Physical Fitness and Subjective Well-Being With Members of a Sports Federation for People With Mental Disorders (Psylos).

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
2
主要终点
Change in well-being pre - post

研究概览

简要总结

The purpose of this study is to investigate the short- and long-term effects of a 10-week walking program, based on the self-determination theory, in people with mental disorders. The investigators expect positive effects on:

  • Physical fitness
  • Physical activity
  • Well-being (less feelings of anxiety, less feelings of depression) The investigators also expect underlying psychosocial processes to influence these effects.

详细描述

Framework: Previous research has shown beneficial health effects of a 10-week walking program in a senior organisation. Based upon the self-determination theory, similar results can be expected in people with mental disorders and could be highly relevant, given the fact that these people:

  • Are often less active
  • Have mental problems and often also comorbidities
  • Are often socially isolated

Participants: Psylos tries to recruit a convenience sample of at least 100 participants for an intervention group (which will undertake the walking program) and 80 participants for a control group. All of them have to sign an informed consent. Due to attrition, at least 60 participants in the intervention group and 40 in the control group can be expected. A post hoc analysis, with detailed information about the variation in this population, may give additional information about the necessary power to obtain significant results.

Data analysis: First there will be examined whether the participants in both groups are equal at baseline according to relevant parameters (due to the non-randomisation). Second, to test the main effects, the difference scores will be examined between both groups. If certain assumptions are met, by an unpaired t-test; if not, by a non-parametric test. Finally (if relevant), the underlying psychosocial processes will be examined by regression analyses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • At least 18 years old
  • Member of Psylos
  • Medically approved by a physician

排除标准

  • 未提供

结局指标

主要结局

Change in well-being pre - post

时间窗: baseline, 10 weeks

Via a questionnaire.

Change in physical fitness pre - follow-up

时间窗: baseline, 6 months

Via 6 minute walk test.

Change in physical activity pre - post

时间窗: baseline, 10 weeks

Via a questionnaire.

Change in physical fitness pre - post

时间窗: baseline, 10 weeks

Via 6 minute walk test.

Change in physical activity pre - follow-up

时间窗: baseline, 6 months

Via a questionnaire.

Change in well-being pre - follow-up

时间窗: baseline, 6 months

Via a questionnaire.

次要结局

  • Change in psychosocial parameters pre - post(baseline, 10 weeks)
  • Change in psychosocial parameters pre - follow-up(baseline, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Filip Boen

Doctor, Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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