Working Memory Training in COPD Patients: the Cogtrain-Trial

NCT03073954 | Completed DMC

• 1 other identifier: NL59883.068.17
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Cognitive Impairment

Keywords

Health Behavior; Executive function; Working-memory training; Feasibility; Impulsivity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Self-control (impulsivity)

  6 months

• Chronic stress levels as measured through hair levels of cortisol

  6 months

• Stress levels as measured through the salivary cortisol awakening response

  6 months

• Stress perception as assessed through a perceived stress scale.

  6 months

• Acute stress as assessed through the socially evaluated cold pressor test

  6 months

Study Arms (2)

Working memory training

ACTIVE COMPARATOR

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

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.

Other: Working memory training; Behavioral: Standardised healthy lifestyle coaching

Interventions

Working memory training OTHER

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.

Sham working memory training; Working memory training

Standardised healthy lifestyle coaching BEHAVIORAL

Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.

Sham working memory training; Working memory training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Eatwell: collaborator

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6200MD, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction; Health Behavior; Impulsive Behavior

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: March 8, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 28, 2022

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)