Investigating the efficacy and feasibility of working memory training in COPD patients on cognitive performance, cognitive stress susceptibility and perception, self-control / impulse control, and adherence to physical activity and dietary…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cognitive performance and feasibility of the trial, measured as the number of
working memory training sessions completed by the participants (adherence), and
their performance therein.
Secondary outcome
Dietary advice compliance, daily physical activity level and pattern, physical
performance, self control / impulsivity, motivation, acute and chronic stress
Background summary
General cognitive impairment is highly prevalent in chronic obstructive
pulmonary disease (COPD) patients. Domain-specific cognitive impairments
include cognitive flexibility, verbal memory, working memory, planning, and
psychomotor speed; which in general are associated with poor lifestyle
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
behaviours including increased physical activity. We 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 objective
Investigating the efficacy and feasibility of working memory training in COPD
patients on cognitive performance, cognitive stress susceptibility and
perception, self-control / impulse control, and adherence to physical activity
and dietary guidelines.
Study design
Double-blind, placebo-controlled randomised clinical trial.
Intervention
During the first twelve-week phase, participants receive at least 25 working
memory training sessions, which are delivered online on a computer. These
sessions take approximately 20-30 minutes. During the second twelve-week phase,
participants receive 'booster sessions' once weekly. These also take 20-30
minutes.
Study burden and risks
Participants will be asked to complete a number of tests, taking half a day, on
four occasions: before baseline, at baseline, after twelve weeks, and after 24
weeks. Additionally, participants are asked to complete approximately 40
working memory training sessions over the course of the 24 weeks (at least 25
in the first twelve weeks, and once weekly in the second twelve-week phase).
These sessions take 20-30 minutes each.
There are minimal risks associated with participating in the current study. No
adverse reactions are known about following a working memory training,
completing questionnaires, or completing brief physical tests. Participants may
feel fatigue after completing the measurements or may lose interest in the
training program. With the lung function test, participants might experience
short-term dizziness and heart palpitations.
Universiteitssingel 40
Maastricht 6200 MD
NL
Universiteitssingel 40
Maastricht 6200 MD
NL
Listed location countries
Age
Inclusion criteria
Diagnosis of COPD
Motivation to participate in the training
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 an inpatient PR programme
Individuals who during the study period are or will be participating in another interventional study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03073954 |
| CCMO | NL59883.068.17 |