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Working Memory Training in COPD Patients: the Cogtrain-Trial

Primary Purpose

COPD, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Working memory training
Standardised healthy lifestyle coaching
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COPD focused on measuring Health Behavior, Executive function, Working-memory training, Feasibility, Impulsivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Working memory training

Sham working memory training

Arm Description

Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching.

Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Self-control (impulsivity)
This will be measured using the stop signal task.
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.
Stress levels as measured through the salivary cortisol awakening response
An objective measure of stress will be measured using salivary cortisol awakening response
Stress perception as assessed through a perceived stress scale.
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
Acute stress will be measured using the socially evaluated cold pressor test, heart rate is also monitored.
Daily physical activity level
Physical activity data will be collected by an accelerometer using step counts.
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)
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)
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.
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.
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.
Changes in dietary intake over the intervention period
Changes in dietary intake over the intervention period will be assessed using a food frequency questionnaire.
Medication adherence
Medication adherence will be measured using a sem
Regulation of Eating Behavior Scale (REBS)
Changes in eating behavior motivation will be investigated using the REBS.
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation
Changes in exercise motivation will be investigated using the BREQ-2
COPD Assessment test (CAT)
Impact of the intervention on quality of life will be done using the brief CAT questionnaire.
Anthropometry
Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).
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.

Full Information

First Posted
January 31, 2017
Last Updated
September 27, 2022
Sponsor
Maastricht University Medical Center
Collaborators
Eatwell
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1. Study Identification

Unique Protocol Identification Number
NCT03073954
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Eatwell

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Cognitive Impairment
Keywords
Health Behavior, Executive function, Working-memory training, Feasibility, Impulsivity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Working memory training
Arm Type
Active Comparator
Arm Description
Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching.
Arm Title
Sham working memory training
Arm Type
Sham Comparator
Arm Description
Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching.
Intervention Type
Other
Intervention Name(s)
Working memory training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standardised healthy lifestyle coaching
Intervention Description
Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.
Primary Outcome Measure Information:
Title
Feasibility of the cognitive training in COPD patients as measured through training compliance.
Description
The compliance as well as the acceptability of working memory training in the COPD patient population will be investigated
Time Frame
6 months
Title
Change in cognitive performance before and after working memory training as assessed through a cognitive test performance battery.
Description
Improvement in cognitive flexibility, planning, and working memory.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Self-control (impulsivity)
Description
This will be measured using the stop signal task.
Time Frame
6 months
Title
Chronic stress levels as measured through hair levels of cortisol
Description
An objective measure of stress levels experienced over the last 3 months will be measured using cortisol extracted from a hair sample.
Time Frame
6 months
Title
Stress levels as measured through the salivary cortisol awakening response
Description
An objective measure of stress will be measured using salivary cortisol awakening response
Time Frame
6 months
Title
Stress perception as assessed through a perceived stress scale.
Description
A subjective measure of chronic stress will be measured using the perceived stress scale score.
Time Frame
6 months
Title
Acute stress as assessed through the socially evaluated cold pressor test
Description
Acute stress will be measured using the socially evaluated cold pressor test, heart rate is also monitored.
Time Frame
6 months
Title
Daily physical activity level
Description
Physical activity data will be collected by an accelerometer using step counts.
Time Frame
6 months
Title
Mental health, depressive symptoms assessed via the BDI-II
Description
Mental health with respect to depression will be evaluated using the Beck Depression Inventory-second edition (BDI-II)
Time Frame
6 months
Title
Mental health, anxiety symptoms assessed via the GAD-7
Description
Mental health with respect to anxiety will be evaluated using the Generalised Anxiety Disorder 7 (GAD-7)
Time Frame
6 months
Title
Physical performance assessed through the 6 minute walk test
Description
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.
Time Frame
6 months
Title
Self-determination questionnaire
Description
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.
Time Frame
6 months
Title
Short Performance Battery
Description
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.
Time Frame
6 months
Title
Changes in dietary intake over the intervention period
Description
Changes in dietary intake over the intervention period will be assessed using a food frequency questionnaire.
Time Frame
6 months
Title
Medication adherence
Description
Medication adherence will be measured using a sem
Time Frame
6 months
Title
Regulation of Eating Behavior Scale (REBS)
Description
Changes in eating behavior motivation will be investigated using the REBS.
Time Frame
6 months
Title
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation
Description
Changes in exercise motivation will be investigated using the BREQ-2
Time Frame
6 months
Title
COPD Assessment test (CAT)
Description
Impact of the intervention on quality of life will be done using the brief CAT questionnaire.
Time Frame
6 months
Title
Anthropometry
Description
Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).
Time Frame
6 months
Title
Manipulation Check
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200MD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Working Memory Training in COPD Patients: the Cogtrain-Trial

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