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临床试验/NCT03073954
NCT03073954
已完成
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The Feasibility of Working Memory Training in COPD Patients and the Efficacy on Cognitive Performance, Self-Control and Stress Response

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 75 人2017年10月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
COPD
发起方
Maastricht University Medical Center
入组人数
75
试验地点
1
主要终点
Feasibility of the cognitive training in COPD patients as measured through training compliance.
状态
已完成
最后更新
3年前

概览

简要总结

General cognitive impairment is highly prevalent in chronic obstructive pulmonary disease (COPD) patients. Domain-specific cognitive impairments include deficits in domains such as cognitive flexibility, verbal memory, working memory, planning, and psychomotor speed; which in general are associated with poor health behaviours, such as infrequent exercising and poor diet. Additional cognitive training may reverse these effects. Recent evidence suggests that working memory training is linked to self-control and, indirectly, to improved lifestyle behaviour including increased physical activity. The investigators hypothesise that enhancing cognitive performance through administering specific working memory training not only improves cognitive function but that it facilitates better adherence to a more active lifestyle and a healthier diet in COPD patients.

注册库
clinicaltrials.gov
开始日期
2017年10月1日
结束日期
2019年7月1日
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • primary diagnosis of COPD based on the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines
  • Patients also need to provide written informed consent
  • Be motivated as evaluated by the self-determination questionnaire

排除标准

  • Disease and or disability limiting the ability to undergo a neuropsychological testing battery and/or to follow a working memory training (e.g., blindness)
  • Neurological disorders (e.g., Alzheimer's Disease or cerebrovascular disease)
  • Insufficient mastery of the Dutch language
  • Individuals who during the study period are or will be participating in a PR programme

结局指标

主要结局

Feasibility of the cognitive training in COPD patients as measured through training compliance.

时间窗: 6 months

The compliance as well as the acceptability of working memory training in the COPD patient population will be investigated

Change in cognitive performance before and after working memory training as assessed through a cognitive test performance battery.

时间窗: 6 months

Improvement in cognitive flexibility, planning, and working memory.

次要结局

  • Stress perception as assessed through a perceived stress scale.(6 months)
  • Acute stress as assessed through the socially evaluated cold pressor test(6 months)
  • Chronic stress levels as measured through hair levels of cortisol(6 months)
  • Daily physical activity level(6 months)
  • Physical performance assessed through the 6 minute walk test(6 months)
  • Self-control (impulsivity)(6 months)
  • Stress levels as measured through the salivary cortisol awakening response(6 months)
  • Mental health, depressive symptoms assessed via the BDI-II(6 months)
  • Mental health, anxiety symptoms assessed via the GAD-7(6 months)
  • Self-determination questionnaire(6 months)
  • Short Performance Battery(6 months)
  • Changes in dietary intake over the intervention period(6 months)
  • Medication adherence(6 months)
  • Regulation of Eating Behavior Scale (REBS)(6 months)
  • COPD Assessment test (CAT)(6 months)
  • Anthropometry(6 months)
  • Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation(6 months)
  • Manipulation Check(6 months)

研究点 (1)

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