NCT05137483

Brief Summary

Within the scope of this study, COPD patients will be divided into two groups according to cognitive dysfunction. Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the groups.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

November 18, 2021

Last Update Submit

November 18, 2021

Conditions

Keywords

copdcognitive impairmentcognitionupper extremity

Outcome Measures

Primary Outcomes (1)

  • 6 min. pegboard ring test

    It is used to measure upper extremity functional capacity.

    6 minutes

Secondary Outcomes (7)

  • Mini Mental State Test

    15 minutes

  • Montreal Cognitive Assessment Scale

    30 minutes

  • Respiratory Function Test

    20 minutes

  • Fatigue Impact Scale

    Time Frame: 20 minutes

  • St. George Respiratory Questionnaire

    20 minutes

  • +2 more secondary outcomes

Study Arms (2)

With cognitive impairment

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the group.

Other: Functional tests

without cognitive impairment

Pulmonary function test, COPD assessment scale, Mini-Mental State Examination and Montreal Cognitive Assessment Scale, 6 min pegboard ring test, grip strength measurement, Fatigue Impact Scale and St.George Respiratory Questionnaire will be applied to the group.

Other: Functional tests

Interventions

We will apply upper extremity performance tests, hand grip measurements, and scales measuring fatigue and quality of life to the groups.

With cognitive impairmentwithout cognitive impairment

Eligibility Criteria

Age45 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COPD patients above 45 years

You may qualify if:

  • Volunteering to participate in the study
  • Stage 2-3-4 according to the GOLD classification in the 40-65 age range

You may not qualify if:

  • Exacerbation of respiratory symptoms in the past 4 weeks (change in breathlessness and/or sputum volume/color, need for antibiotic treatment or need for hospitalization)
  • Presence of asthma, unstable coronary heart disease, uncontrolled diabetes, hypertension, left-sided congestive heart failure, neoplasia, severe claudication, encephalitis or epilepsy
  • Having a history of head trauma or brain tumor
  • Having a significant psychiatric condition or the presence of defined dementia, according to the American Psychiatric Association

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveCognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

November 18, 2021

First Posted

November 30, 2021

Study Start

November 19, 2021

Primary Completion

June 30, 2022

Study Completion

July 30, 2022

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share