- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05113732
Association of Cognition With Functional Mobility in People With Alzheimer's Disease
October 28, 2021 updated by: Kübra Nur Menengiç, Istanbul University - Cerrahpasa (IUC)
This study aimed to investigate relationship between cognitive function and functional mobility in Alzheimer's disease.
Study Overview
Status
Not yet recruiting
Detailed Description
Our hypothesis is that the decrease in cognitive function in individuals with Alzheimer's disease is associated with the level of functional mobility.
Sociodemographic information of participants will be recorded.
Cognition will assessed with Montreal Cognitive Assessment (MoCA), global score and MoCA's visuospatial executive functions, naming, attention, language, abstract thinking, delayed recall, orientation sub-scores will recorded.
Functional mobility will assessed Timed Up and Go Test and 5 Times Sit&Stand Test.
Study Type
Observational
Enrollment (Anticipated)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kübra Nur Menengiç, MSc
- Phone Number: +90 05054400987
- Email: kmenengic@gmail.com
Study Contact Backup
- Name: İpek Yeldan, PhD
- Phone Number: 43306 +90 0 (212) 866 37 00
- Email: ipek.yeldan@iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey
- Istanbul University-Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
People with Alzheimer's disease
Description
Inclusion Criteria:
- Diagnosed with Alzheimer's disease according to the National Institute of --Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
- Over 65 years old,
- Cases who could understand the instructions given in Turkish were included in the study,
- Having ambulation skill independently or with walking aid.
Exclusion Criteria:
- Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
- Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
- Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
- Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Cognitive Assesment (MoCA)
Time Frame: Baseline
|
MoCA assesses cognitive skills such as visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation.
Higher scores reflect the better performance.
|
Baseline
|
Timed Up and Go Test
Time Frame: Baseline
|
Timed Up and Go Test measures the level of functional mobility skills and, assess fall risk and balance.
The time elapsed between standing up from the sitting position, walking the distance of 3 meters, coming back and sitting back on the chair is recorded.
The shorter time reflect the better performance.
|
Baseline
|
5 Time Sit to Stand Test
Time Frame: Baseline
|
5 Time Sit to Stand Test measures the level of functional mobility skills and, assess fall risk and lower extremity strength.
The test measures the time taken to stand five times from a sitting position as quickly as possible.
The shorter time reflect the better performance.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
October 28, 2021
First Submitted That Met QC Criteria
October 28, 2021
First Posted (Actual)
November 9, 2021
Study Record Updates
Last Update Posted (Actual)
November 9, 2021
Last Update Submitted That Met QC Criteria
October 28, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUC-PT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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