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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05834322
Other study ID # NCUEREC-112-009
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date August 30, 2024

Study information

Verified date April 2023
Source National Changhua University of Education
Contact Yu-Hsuan Lee
Phone +886975690234
Email xuanyolee@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date August 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan National Chunghua University of education Changhua

Sponsors (1)

Lead Sponsor Collaborator
National Changhua University of Education

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cognitive function Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess cognitive function at the time the participants enroll
Primary Sleep quality Chinese version of The Pittsburgh Sleep Quality Index (PSQI) will be use to assess sleep quality at the time the participants enroll
Primary Physical activity levels 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
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