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ThinkingFit: Combined Physical, Cognitive and Social Treatment in Mild Cognitive Impairment (MCI) (ThinkingFit)

2014年4月25日 更新者:Dr Thomas Dannhauser

Piloting a Complex Intervention Involving Physical Exercise, Cognitive Training and Socialising to Delay the Onset of Dementia in Mild Cognitive Impairment

Dementia is serious problem and around 700 000 people are affected in the UK alone. Currently there is no cure however early diagnosis and effective treatment offers hope for reducing the impact. Dementia sufferers require care due to physical disability, cognitive deficits, social isolation and emotional symptoms (depression). Delaying the onset of dementia will improve quality of life for patients and reduce the cost of residential care (£42 000 per person per year).

People with mild cognitive impairment (MCI) are at high risk of developing dementia. They have impaired cognitive abilities, such as memory, but still manage their everyday activities. Studies show that 8 out of 10 people with MCI will have developed dementia 6 years after diagnosis.

Regular physical activities and performing a variety of cognitive activities reduce the risk of dementia and improves abilities and quality of life in healthy people. Therefore a combination of these activities may reduce the risk of developing dementia in MCI. The investigators want to see if they can develop a program which combines these activities in a fun and social way that gets people active and keeps them active. The aims are to improve fitness, cognition and quality of life. The investigators plan to use computers and the internet to help with the activities and to make them available to people who are isolated. Physical activity will involve walking from home, cognitive activities will be computer based games and puzzles and socialising will involve regular varied group-based activities. Participants (128) will be recruited from the UCL Derwent Memory Clinic and will complete a 26 week program. They will then be followed up yearly to monitor their progress. The main outcome of the study is engagement in the activities. The investigators will also measure fitness, cognition, quality of life and conversion to dementia.

研究概览

地位

完全的

研究类型

介入性

注册 (预期的)

128

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Essex
      • Harlow、Essex、英国、cm20 1qx
        • North Essex Partnership Foundation NHS Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria for patients with MCI

  1. Patients fulfilling criteria for AMCI [Petersen et al. 2001b]:

    i. Memory impairment for age and education ii. No impairment in other cognitive domains iii. Normal social activities iv. Patient is not demented

  2. For the other subtypes of MCI, cognitive impairment in one or more nonmemory domain
  3. Sedentary lifestyle with no regular participation in physical exercise defined as two or three times a week for at least 20 minutes duration, or participation in active sport more than once a week, in the previous six months.
  4. Willing and able to give informed consent.
  5. Availability and access to safe exercise environments, such as paths or roads with sidewalks for walking or cycling.
  6. At low risk from serious adverse effects from increased physical activity as indicated by performance on the revised Physical activity readiness questionnaire (PARQ).

Exclusion Criteria:

Exclusion criteria for patients with MCI

  1. Type 1 (insulin dependent) diabetes mellitus.
  2. Blood pressure of 160/100 mmHg or more.
  3. Body weight more than 140% of ideal body weight.
  4. Musculoskeletal or other medical problems preventing safe participation in regular moderate intensity exercise (65-77% of predicted maximum heart rate). This will include a resting tachycardia (heart rate above 100 bpm) and history of myocardial infarction or unstable angina within the last month.

Participants with modifiable exclusion criteria will be reconsidered after successful management. Patients will be referred for medical treatment prior to commencing exercise if indicated by the PARQ and the intervention will be guided by the PARmedX.

Participants taking medications affecting heart rate will need to be on a stable dosing regime for 3 months prior to commencing in order to control for potential spurious results on fitness measures caused by these treatments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:ThinkingFit
Combined physical, cognitive and social stimulation activties.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Activity Compliance
大体时间:Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks
Number of participants to have completed 50% or more of the programmed activity sessions during the intervention period.
Compliance with programmed activities will be assessed at the end of participation which is expected to be at 24 weeks

次要结果测量

结果测量
措施说明
大体时间
Cardiovascular fitness measure
大体时间:This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Cardiovascular fitness will be measured with a modified Siconolfi Step Test.
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Cognitive measures
大体时间:This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.

Participants will complete the following cognitive measures:

  • Visual and auditory divided attention task
  • Verbal episodic encoding and recognition task
  • Halstead Trail Making test (TMT)
  • Verbal fluency
  • Working memory tests: digit span forwards/ backwards
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Measures of quality of life and everyday activities
大体时间:This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.
Quality of life will be measured on the World Health Organization Quality of Life (WHOQOL) - BREF and change in every day activities on the Alzheimer's Disease Cooperative Study MCI Activities of Daily Living Scale (ADCS-MCI-ADL)
This will be measured at the start, after the control period (12 weeks) and after completion of the activity interventions at around 24 weeks.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Martin Cleverley、North Essex Partnership Foundation NHS Trust
  • 研究主任:Thomas M Dannhauser, PhD、University College London, North Essex Partnership NHS Foundation Trust

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年1月1日

初级完成 (实际的)

2012年11月1日

研究完成 (实际的)

2012年11月1日

研究注册日期

首次提交

2012年5月17日

首先提交符合 QC 标准的

2012年5月20日

首次发布 (估计)

2012年5月23日

研究记录更新

最后更新发布 (估计)

2014年4月28日

上次提交的符合 QC 标准的更新

2014年4月25日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • ThinkingFit 1

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