COPD
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Inhaler Technique, Cognitive Load, Dual-Task Performance, Timed Up and Go
Brief summary
This study evaluates whether cognitive load affects inhaler technique in adults with chronic obstructive pulmonary disease (COPD). During a single study visit, participants will complete assessments of cognitive function, mobility, and respiratory status. Dual-task mobility will be assessed using the Timed Up and Go test performed alone and while completing a cognitive task. Inhaler technique will then be evaluated in two conditions: usual inhaler use without an additional task and inhaler use while maintaining a short sequence of digits in working memory. Inhaler technique will be scored using a standardized five-step device-specific checklist, and inhaler use time will also be recorded. The study will examine whether inhaler technique worsens under cognitive load and whether this deterioration is associated with dual-task mobility performance, cognitive function, respiratory symptoms, and functional capacity. No inhaler training or correction will be provided between the two inhaler conditions. All assessments are performed during a single visit.
Interventions
BEHAVIORALWorking-Memory Cognitive Load During Inhaler Use
Participants are presented with a standardized five-digit sequence before inhaler use and are instructed to retain the sequence in working memory while completing their usual inhaler technique. The sequence is presented once at approximately one digit per second. Participants do not verbalize the digits during inhaler use. Immediately after completing the inhaler maneuver, they reproduce the sequence in reverse order. Inhaler technique is simultaneously assessed using a standardized five-item device-specific checklist, and inhaler-use time is recorded.
BEHAVIORALSingle-Task Inhaler Use
Participants use their usual maintenance inhaler without a concurrent cognitive task. They are instructed to use the inhaler as they normally do at home. Inhaler technique is assessed using the same standardized five-item device-specific checklist, and inhaler-use time is recorded. No inhaler-technique training, correction, or feedback is provided before completion of both study conditions.
Sponsors
Spitalul Clinic de Boli Infecțioase și Pneumoftiziologie Dr. Victor Babeș Timișoara
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Each participant completes both inhaler-use conditions during a single study visit: single-task inhaler use and inhaler use under working-memory cognitive load. The order of the two conditions is assigned according to one of two predefined sequences.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Confirmed diagnosis of chronic obstructive pulmonary disease (COPD) * Clinically stable at the time of assessment * Current use of at least one handheld maintenance inhaler (pMDI, SMI, or DPI) * Able to understand and follow study instructions * Able to perform the Timed Up and Go test * Able to complete the cognitive tasks and inhaler technique assessment * Able and willing to provide written informed consent
Exclusion criteria
* Recent COPD exacerbation with incomplete recovery to baseline clinical status * Acute respiratory or other acute medical condition at the time of assessment * Known severe cognitive impairment or dementia that prevents completion of study procedures * Neurological or musculoskeletal impairment that prevents safe completion of the Timed Up and Go test * Severe visual, hearing, or communication impairment that prevents completion of the cognitive or inhaler tasks * Inability to independently handle or use the study inhaler device for assessment purposes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inhaler Technique Performance Under Cognitive Load | During the single study visit, immediately after completion of both inhaler conditions | Difference in the number of satisfactory inhaler-technique steps between the cognitive dual-task condition and the single-task condition, assessed using the same standardized 5-item device-specific inhaler technique checklist. Each checklist item is scored as 1 = satisfactory or 0 = unsatisfactory/omitted, yielding a total score of 0 to 5 for each condition. The primary outcome is calculated as dual-task satisfactory score minus single-task satisfactory score, with a possible range from -5 to +5. Negative values indicate deterioration of inhaler technique under cognitive load. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Inhaler Error Under Cognitive Load | During the single study visit, immediately after completion of both inhaler conditions | Binary outcome indicating whether inhaler technique deteriorates under cognitive load. A new inhaler error is defined as having fewer satisfactory items on the standardized 5-item inhaler technique checklist during the cognitive dual-task condition than during the single-task condition. Coded as 1 = deterioration under cognitive load and 0 = no deterioration. |
| Worsening of Inhaler Technique Classification Under Cognitive Load | During the single study visit, immediately after completion of both inhaler conditions | Binary outcome indicating whether the participant's inhaler technique classification worsens from Acceptable during the single-task condition to Unacceptable during the cognitive dual-task condition. Inhaler technique is classified using the standardized 5-item checklist, with 4-5 satisfactory steps classified as Acceptable and 0-3 satisfactory steps classified as Unacceptable. Coded as 1 = classification worsened and 0 = no worsening. |
| Inhaler Time Dual-Task Cost | During the single study visit, immediately after completion of both inhaler conditions | Percentage change in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as \[(dual-task inhaler time - single-task inhaler time) / single-task inhaler time\] × 100. Positive values indicate slower inhaler use under cognitive load. |
| Inhaler Cognitive Dual-Task Cost | During the single study visit, immediately after completion of the inhaler cognitive assessments | Percentage change in working-memory performance between the cognitive single-task condition and the inhaler cognitive dual-task condition. It is calculated as \[(single-task cognitive accuracy - dual-task cognitive accuracy) / single-task cognitive accuracy\] × 100. Positive values indicate poorer cognitive performance while using the inhaler under cognitive load. |
| Physical Dual-Task Cost During Timed Up and Go | During the single study visit, immediately after completion of the single-task and dual-task Timed Up and Go assessments | Percentage increase in Timed Up and Go completion time during the cognitive dual-task condition compared with the single-task condition. It is calculated as \[(TUG dual-task time - TUG single-task time) / TUG single-task time\] × 100. Positive values indicate slower mobility performance during dual-tasking. |
| Cognitive Dual-Task Cost During Timed Up and Go | During the single study visit, immediately after completion of the cognitive single-task and dual-task Timed Up and Go assessments | Percentage reduction in cognitive performance during the dual-task Timed Up and Go condition compared with the cognitive single-task condition. Cognitive performance is quantified using the rate of correct responses per second. The outcome is calculated as \[(single-task correct-response rate - dual-task correct-response rate) / single-task correct-response rate\] × 100. Positive values indicate poorer cognitive performance during dual-task walking. |
| Change in Inhaler Completion Time Under Cognitive Load | During the single study visit, immediately after completion of both inhaler conditions | Absolute difference in inhaler-use time between the cognitive dual-task and single-task conditions. It is calculated as dual-task inhaler time minus single-task inhaler time, expressed in seconds. Positive values indicate longer inhaler-use time under cognitive load. |
Countries
Romania
Contacts
CONTACTAlexandru Crișan
Outcome results
None listed