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).
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
- 否
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
Prof Filip Boen
Doctor, Professor
Universitaire Ziekenhuizen KU Leuven
