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临床试验/NCT03212859
NCT03212859已完成不适用

Coach2Move: Sustainable in Daily Practice

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2017年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
292
试验地点
2
主要终点
Self-reported Physical Activity

研究概览

简要总结

Implementation of a previously shown (cost-)effective physical therapeutic treatment strategy for community-dwelling older adults.

详细描述

In a previous trial, researchers demonstrated that the Coach2Move approach is superior to regular physiotherapy in terms of increasing physical activity, reducing frailty, improving quality of life and reducing healthcare costs. In short, in less physiotherapeutic sessions, better outcomes were realized.

Despite these promising findings, the research group still has questions regarding the generalisability of these findings. The reservations towards the generalisability of the approach are caused by the following:

  1. A modest (n=130), yet somewhat selective study sample was included: nearly half of the eligible individuals declined randomisation and thereby participation. An understanding is needed how this group of eligible non volunteers respond to Coach2Move. Therefore, a study design that avoids randomisation at the patient level will be used.
  2. The Coach2Move approach significantly increased the level of moderate physical activity among the treatment group and reduced levels of frailty significantly after 6 months, but the clinical importance of these findings is still unclear. Thus, a replication of the effects in the light of physical functioning is needed in a larger more variable study population and with a longer follow-up.

In addition, the results from the earlier carried out RCT concerning the cost-effectiveness of Coach2Move have to be replicated on a larger scale.

For the reasons mentioned above, it is important to further implement Coach2Move and study its effect, costs, and feasibility in current practice. A stepped wedge cluster randomised trial design is chosen because in the opinion of the researchers, the implementation strategy will do more good than harm (making a parallel design, in which certain practices do not receive the intervention or to withdraw the intervention as would occur in a cross-over design, is unethical) and it furthermore minimizes contamination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 70 years or older
  • Community-dwelling
  • mobility related problems or problems related to activities of daily living
  • sedentary lifestyle or are at risk of losing an active lifestyle

排除标准

  • Patients who are not ambulatory after treatment and/or are in palliative phase.
  • Patients who are indicated to become institutionalised in the near future.

结局指标

主要结局

Self-reported Physical Activity

时间窗: 27 months

The primary outcome of the study is physical activity measured by the LAPAQ questionnaire, subscale moderate activity. This subscale of the LAPAQ is a comprehensive questionnaire on diverse (physical) activities of daily living with moderate intensity including walking, riding a bicycle etc. and is specifically designed to assess habitual physical activity of the elderly.

Functional Mobility

时间窗: 27 months

The key secondary outcome is functional mobility as measured by the Timed Up and Go test.

次要结局

  • Functional Status(12 months)
  • Cost effectiveness(27 months)
  • Patient Satisfaction(27 months)
  • Level of Frailty(27 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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