Working Memory Training in COPD Patients: the Cogtrain-Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; COPD
• Intervention / Treatment: Other: Working memory training; Behavioral: Standardised healthy lifestyle coaching

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200MD
      • Maastricht University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Working memory training; Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching.	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.
SHAM_COMPARATOR: Sham working memory training; Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-control (impulsivity)	This will be measured using the stop signal task.	6 months
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
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
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
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
Daily physical activity level	Physical activity data will be collected by an accelerometer using step counts.	6 months
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
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
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
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
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
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
Medication adherence	Medication adherence will be measured using a sem	6 months
Regulation of Eating Behavior Scale (REBS)	Changes in eating behavior motivation will be investigated using the REBS.	6 months
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation	Changes in exercise motivation will be investigated using the BREQ-2	6 months
COPD Assessment test (CAT)	Impact of the intervention on quality of life will be done using the brief CAT questionnaire.	6 months
Anthropometry	Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).	6 months
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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Eatwell

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2017
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (ACTUAL): March 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Feasibility; Impulsivity; Executive function; Health Behavior; Working-memory training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: NL59883.068.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No