Clinical trial NCT03073954: Working Memory Training in COPD Patients: the Cogtrain-Trial
Official title: The Feasibility of Working Memory Training in COPD Patients and the Efficacy on Cognitive Performance, Self-Control and Stress Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Cognitive Impairment
Keywords: Health Behavior
Executive function
Working-memory training
Feasibility
Impulsivity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Eatwell
First posted: 2017-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of the cognitive training in COPD patients as measured through training compliance.
timeFrame: 6 months
measure: Change in cognitive performance before and after working memory training as assessed through a cognitive test performance battery.
timeFrame: 6 months
Secondary outcomes:
measure: Self-control (impulsivity)
timeFrame: 6 months
measure: Chronic stress levels as measured through hair levels of cortisol
timeFrame: 6 months
measure: Stress levels as measured through the salivary cortisol awakening response
timeFrame: 6 months
measure: Stress perception as assessed through a perceived stress scale.
timeFrame: 6 months
measure: Acute stress as assessed through the socially evaluated cold pressor test
timeFrame: 6 months
measure: Daily physical activity level
timeFrame: 6 months
measure: Mental health, depressive symptoms assessed via the BDI-II
timeFrame: 6 months
measure: Mental health, anxiety symptoms assessed via the GAD-7
timeFrame: 6 months
measure: Physical performance assessed through the 6 minute walk test
timeFrame: 6 months
measure: Self-determination questionnaire
timeFrame: 6 months
measure: Short Performance Battery
timeFrame: 6 months
measure: Changes in dietary intake over the intervention period
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Regulation of Eating Behavior Scale (REBS)
timeFrame: 6 months
measure: Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation
timeFrame: 6 months
measure: COPD Assessment test (CAT)
timeFrame: 6 months
measure: Anthropometry
timeFrame: 6 months
measure: Manipulation Check
timeFrame: 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: