Cognitive Impairment, COPD
Conditions
Keywords
Health Behavior, Executive function, Working-memory training, Feasibility, Impulsivity
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.
Interventions
OTHERWorking memory training
The working memory intervention training programme consists of a domain-general cognitive working memory training programme. One training session will take 20 to 30 minutes, and participants will have to complete approximately 40 cognitive training sessions. The sham treatment is the same as the intervention training however it does not increase in difficulty. Participants are presented with the same task at the same level of difficulty over and over again. Thus a training effect is not expected.
BEHAVIORALStandardised healthy lifestyle coaching
Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.
Sponsors
Eatwell
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| Daily physical activity level | 6 months | Physical activity data will be collected by an accelerometer using step counts. |
| 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) |
| 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-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. |
| Self-control (impulsivity) | 6 months | This will be measured using the stop signal task. |
| 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. |
| Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation | 6 months | Changes in exercise motivation will be investigated using the BREQ-2 |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
Netherlands
Outcome results
None listed