NCT05834322

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 17, 2023

Last Update Submit

April 17, 2023

Conditions

Keywords

physical activitycognitive functionsleepolder adults

Outcome Measures

Primary Outcomes (3)

  • Cognitive function

    Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess cognitive function

    at the time the participants enroll

  • Sleep quality

    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

    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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants should be over 65 and haven't been diagnosed with MCI or dementia.

You may qualify if:

  • aged above 65
  • haven't been diagnosed with MCI or dementia
  • be able to read and write in Chinese

You may not qualify if:

  • elders who unable to talk or communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Chunghua University of education

Changhua, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

April 17, 2023

First Posted

April 28, 2023

Study Start

April 1, 2023

Primary Completion

April 30, 2024

Study Completion

August 30, 2024

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations