COPDNCT03073954
Working Memory Training in COPD Patients: the Cogtrain-Trial
A study testing Working memory training and Standardised healthy lifestyle coaching in people with COPD and Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Cognitive Impairment
- What is being tested?
- Working memory training and Standardised healthy lifestyle coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COPD, Cognitive Impairment
- Being tested
- Working memory training, Standardised healthy lifestyle coaching
- Keywords
- Health Behavior, Executive function, Working-memory training, Feasibility, Impulsivity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction, Health Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingOther
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.
Standardised healthy lifestyle coachingBehavioural
Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Working memory training | Active comparator | Working memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching. Receives: Other: Working memory training; Behavioral: Standardised healthy lifestyle coaching |
| Sham working memory training | Sham comparator | Working memory training that does not increase in difficulty, and standardised healthy lifestyle coaching. Receives: Other: Working memory training; Behavioral: Standardised healthy lifestyle coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 6 months
Secondary outcomes (18)
Self-control (impulsivity)
This will be measured using the stop signal task.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Daily physical activity level
Physical activity data will be collected by an accelerometer using step counts.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Medication adherence
Medication adherence will be measured using a sem
Measured: 6 months
Regulation of Eating Behavior Scale (REBS)
Changes in eating behavior motivation will be investigated using the REBS.
Measured: 6 months
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation
Changes in exercise motivation will be investigated using the BREQ-2
Measured: 6 months
COPD Assessment test (CAT)
Impact of the intervention on quality of life will be done using the brief CAT questionnaire.
Measured: 6 months
Anthropometry
Alterations in Anthropometical measures will be evaluated using waist circumference, biometric impedance, and body weight (BMI).
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Oct 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eatwell
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073954
- Sponsor's protocol ID
- NL59883.068.17
- Status last verified
- Mar 2018
- First submitted
- 31 Jan 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Working Memory Training in COPD Patients and the Efficacy on Cognitive Performance, Self-Control and Stress Response
- ClinicalTrials.gov ID
- NCT03073954
- Acronym / sponsor ID
- NL59883.068.17
- Conditions
- COPD, Cognitive Impairment
- Keywords
- Health Behavior, Executive function, Working-memory training, Feasibility, Impulsivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Eatwell
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working memory training | Active comparator | Other: Working memory training, Behavioral: Standardised healthy lifestyle coachingWorking memory training that increases with difficulty if participants answer two subsequent questions correctly, and standardised healthy lifestyle coaching. |
| Sham working memory training | Sham comparator | Other: Working memory training, Behavioral: Standardised healthy lifestyle coachingWorking memory training that does not increase in difficulty, and standardised healthy lifestyle coaching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working memory trainingThe 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. | Other | Sham working memory training, Working memory training |
| Standardised healthy lifestyle coachingParticipants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity. | Behavioural | Sham working memory training, Working memory training |
Primary outcome
Feasibility of the cognitive training in COPD patients as measured through training compliance.
Time frame: 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.
Time frame: 6 months
Improvement in cognitive flexibility, planning, and working memory.
18 secondary outcomes
Self-control (impulsivity)
Time frame: 6 months
Chronic stress levels as measured through hair levels of cortisol
Time frame: 6 months
Stress levels as measured through the salivary cortisol awakening response
Time frame: 6 months
Stress perception as assessed through a perceived stress scale.
Time frame: 6 months
Acute stress as assessed through the socially evaluated cold pressor test
Time frame: 6 months
Daily physical activity level
Time frame: 6 months
Mental health, depressive symptoms assessed via the BDI-II
Time frame: 6 months
Mental health, anxiety symptoms assessed via the GAD-7
Time frame: 6 months
Physical performance assessed through the 6 minute walk test
Time frame: 6 months
Self-determination questionnaire
Time frame: 6 months
Short Performance Battery
Time frame: 6 months
Changes in dietary intake over the intervention period
Time frame: 6 months
Medication adherence
Time frame: 6 months
Regulation of Eating Behavior Scale (REBS)
Time frame: 6 months
Behavioral Regulation in Exercise Questionnaire-2 (BREQ-2) Regulation
Time frame: 6 months
COPD Assessment test (CAT)
Time frame: 6 months
Anthropometry
Time frame: 6 months
Manipulation Check
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working memory training and Standardised healthy lifestyle coaching in people with COPD and Cognitive Impairment, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the cognitive training in COPD patients as measured through training compliance. (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.