- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834322
Exercise, PA, Sleep Quality and Cognitive Function Among Older Adults.
April 17, 2023 updated by: Yu-Hsuan Lee, National Changhua University of Education
Relationship Between Exercise, Physical Activity Levels, Sleep Quality and Cognitive Function Among Older Adults.
The rapid increase in the prevalence of dementia in Taiwan poses an economic burden on healthcare systems as well as the families of the patients.
Thus, how to prevent dementia is a crucial issue.
Mild cognitive impairment (MCI) is defined as cognitive decline objectively and subjectively and it has been deemed as a transitional state between normal cognition and dementia.
Identifying and preventing MCI can be a venue for reducing the prevalence of dementia.
Sleep and physical activity are modifiable risk factors of MCI.
Both factors could influence brain structure, such as the volume of the hippocampus.
As a result, physical activity and adequate sleep are helpful to prevent the decline of cognitive function.
In addition, sleep could regulate physical activity and change cognitive function indirectly.
To our knowledge, there has been no research investigating the relationship between sleep, physical activity, and cognitive function in Taiwan.
Hence, this research will aim to explore the relationship between sleep, physical activity, and cognitive function.
Whether sleep and physical activity can be predictors of MCI will be investigated.
We will recruit 150 participants aged above 65, who haven't been diagnosed with MCI or dementia.
The measurements will include the Chinese version of The Pittsburgh Sleep Quality Index (PSQI), the Chinese Version of the Physical Activity Scale for the Elderly (PASE-C), and the Chinese version of Montreal Cognitive Assessment (MoCA).
The relationship between sleep, physical activity level, and cognitive function will be analyzed by multiple linear regression and Pearson correlations.
A prediction equation will be established.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
150
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: Yu-Hsuan Lee
- Phone Number: +886975690234
- Email: xuanyolee@gmail.com
Study Locations
-
-
-
Changhua, Taiwan, 500
- Recruiting
- National Chunghua University of education
-
Contact:
- Yu-Hsuan Lee
- Phone Number: +886975690234
- Email: xuanyolee@gmail.com
-
Sub-Investigator:
- Yu-Hsuan Lee
-
-
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
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Participants should be over 65 and haven't been diagnosed with MCI or dementia.
Description
Inclusion Criteria:
- aged above 65
- haven't been diagnosed with MCI or dementia
- be able to read and write in Chinese
Exclusion Criteria:
- elders who unable to talk or communicate
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive function
Time Frame: at the time the participants enroll
|
Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess cognitive function
|
at the time the participants enroll
|
Sleep quality
Time Frame: at the time the participants enroll
|
Chinese version of The Pittsburgh Sleep Quality Index (PSQI) will be use to assess sleep quality
|
at the time the participants enroll
|
Physical activity levels
Time Frame: at the time the participants enroll
|
Chinese Version of the Physical Activity Scale for the Elderly (PASE-C) will be use to assess physical activity levels
|
at the time the participants enroll
|
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 (Actual)
April 1, 2023
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
August 30, 2024
Study Registration Dates
First Submitted
April 17, 2023
First Submitted That Met QC Criteria
April 17, 2023
First Posted (Actual)
April 28, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 17, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NCUEREC-112-009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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