Working Memory Training in COPD Patients: the Cogtrain-Trial

COPD Clinical Trial

Official title:

The Feasibility of Working Memory Training in COPD Patients and the Efficacy on Cognitive Performance, Self-Control and Stress Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073954
• Other study ID #: NL59883.068.17
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• COPD

Intervention

Other:
• Working 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.

Behavioral:
• Standardised healthy lifestyle coaching
Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Eatwell

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the cognitive training in COPD patients as measured through training compliance.	The compliance as well as the acceptability of working memory training in the COPD patient population will be investigated	6 months
Primary	Change in cognitive performance before and after working memory training as assessed through a cognitive test performance battery.	Improvement in cognitive flexibility, planning, and working memory.	6 months
Secondary	Self-control (impulsivity)	This will be measured using the stop signal task.	6 months
Secondary	Chronic stress levels as measured through hair levels of cortisol	An objective measure of stress levels experienced over the last 3 months will be measured using cortisol extracted from a hair sample.	6 months
Secondary	Stress levels as measured through the salivary cortisol awakening response	An objective measure of stress will be measured using salivary cortisol awakening response	6 months
Secondary	Stress perception as assessed through a perceived stress scale.	A subjective measure of chronic stress will be measured using the perceived stress scale score.	6 months
Secondary	Acute stress as assessed through the socially evaluated cold pressor test	Acute stress will be measured using the socially evaluated cold pressor test, heart rate is also monitored.	6 months
Secondary	Daily physical activity level	Physical activity data will be collected by an accelerometer using step counts.	6 months
Secondary	Mental health, depressive symptoms assessed via the BDI-II	Mental health with respect to depression will be evaluated using the Beck Depression Inventory-second edition (BDI-II)	6 months
Secondary	Mental health, anxiety symptoms assessed via the GAD-7	Mental health with respect to anxiety will be evaluated using the Generalised Anxiety Disorder 7 (GAD-7)	6 months
Secondary	Physical performance assessed through the 6 minute walk test	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.	6 months
Secondary	Self-determination questionnaire	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.	6 months
Secondary	Short Performance Battery	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.	6 months
Secondary	Changes in dietary intake over the intervention period	Changes in dietary intake over the intervention period will be assessed using a food frequency questionnaire.	6 months
Secondary	Medication adherence	Medication adherence will be measured using a sem	6 months
Secondary	Regulation of Eating Behavior Scale (REBS)	Changes in eating behavior motivation will be investigated using the REBS.	6 months
Secondary	Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation	Changes in exercise motivation will be investigated using the BREQ-2	6 months
Secondary	COPD Assessment test (CAT)	Impact of the intervention on quality of life will be done using the brief CAT questionnaire.	6 months
Secondary	Anthropometry	Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).	6 months
Secondary	Manipulation Check	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.	6 months