Working Memory Training in COPD Patients: the Cogtrain-Trial
- Conditions
- COPDCognitive Impairment
- Interventions
- Other: Working memory trainingBehavioral: Standardised healthy lifestyle coaching
- Registration Number
- NCT03073954
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Working memory training Standardised healthy lifestyle coaching Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching. Sham working memory training Standardised healthy lifestyle coaching Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching. Working memory training Working memory training Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching. Sham working memory training Working memory training Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.
- Primary Outcome Measures
Name Time Method Feasibility of the cognitive training in COPD patients as measured through training compliance. 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. 6 months Improvement in cognitive flexibility, planning, and working memory.
- Secondary Outcome Measures
Name Time Method Stress perception as assessed through a perceived stress scale. 6 months A subjective measure of chronic stress will be measured using the perceived stress scale score.
Acute stress as assessed through the socially evaluated cold pressor test 6 months Acute stress will be measured using the socially evaluated cold pressor test, heart rate is also monitored.
Chronic stress levels as measured through hair levels of cortisol 6 months An objective measure of stress levels experienced over the last 3 months will be measured using cortisol extracted from a hair sample.
Daily physical activity level 6 months Physical activity data will be collected by an accelerometer using step counts.
Physical performance assessed through the 6 minute walk test 6 months Changes in physical performance will be assessed using the 6-minute walking test (6MWT).Two six-minute walk tests (6MWT) will be performed according to ERS/ATS guidelines to measure functional exercise capacity. The best 6MWT will be expressed in percentage of predicted values.
Self-control (impulsivity) 6 months This will be measured using the stop signal task.
Stress levels as measured through the salivary cortisol awakening response 6 months An objective measure of stress will be measured using salivary cortisol awakening response
Mental health, depressive symptoms assessed via the BDI-II 6 months Mental health with respect to depression will be evaluated using the Beck Depression Inventory-second edition (BDI-II)
Mental health, anxiety symptoms assessed via the GAD-7 6 months Mental health with respect to anxiety will be evaluated using the Generalised Anxiety Disorder 7 (GAD-7)
Self-determination questionnaire 6 months Motivation will be prior to the enrolment of participants in this study in order to include patients who are motivated to initiate and continue our working memory training. The self-made questionnaire evaluates patient's reasons for participating in the study in order to assess their intrinsic motivation.
Short Performance Battery 6 months The SPPB consists of three types of physical manoeuvres: the balance tests, the gait speed test, and the chair stand test. The results of the different tests result in a score which will be used for analysis.
Changes in dietary intake over the intervention period 6 months Changes in dietary intake over the intervention period will be assessed using a food frequency questionnaire.
Medication adherence 6 months Medication adherence will be measured using a sem
Regulation of Eating Behavior Scale (REBS) 6 months Changes in eating behavior motivation will be investigated using the REBS.
COPD Assessment test (CAT) 6 months Impact of the intervention on quality of life will be done using the brief CAT questionnaire.
Anthropometry 6 months Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation 6 months Changes in exercise motivation will be investigated using the BREQ-2
Manipulation Check 6 months Participants will be asked to recall key health messages from their personalized healthy lifestyle advice sessions. Responses will be scored as follows: 0 points - field blank or no recall of the message content; 1 point - key points not directly related to the message themes; 2 points - key points directly related to the message themes.
Trial Locations
- Locations (1)
Maastricht University
🇳🇱Maastricht, Limburg, Netherlands