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临床试验/NCT03073954
NCT03073954已完成不适用

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 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
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.

研究概览

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •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

研究组 & 干预措施

Working memory training

Active Comparator

Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching.

干预措施: Standardised healthy lifestyle coaching (Behavioral)

Sham working memory training

Sham Comparator

Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.

干预措施: Working memory training (Other)

Sham working memory training

Sham Comparator

Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.

干预措施: Standardised healthy lifestyle coaching (Behavioral)

Working memory training

Active Comparator

Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching.

干预措施: Working memory training (Other)

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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