Cognitive FunctionNCT05834322
Exercise, PA, Sleep Quality and Cognitive Function Among Older Adults.
An observational study of Cognitive Function, run by National Changhua University of Education at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants should be over 65 and haven't been diagnosed with MCI or dementia.
Who may be able to join
- aged above 65
- haven't been diagnosed with MCI or dementia
- be able to read and write in Chinese
Who cannot join
- elders who unable to talk or communicate
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Chunghua University of education
Changhua, 500
Yu-Hsuan Lee, +886975690234, xuanyolee@gmail.com
Yu-Hsuan Lee
About this study
Official title: 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.
- Conditions
- Cognitive Function
- Keywords
- physical activity, cognitive function, sleep, older adults
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess cognitive function
Measured: at the time the participants enroll
Sleep quality
Chinese version of The Pittsburgh Sleep Quality Index (PSQI) will be use to assess sleep quality
Measured: 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
Measured: at the time the participants enroll
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Apr 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Changhua University of Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Hsuan Lee, National Changhua University of Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834322
- Sponsor's protocol ID
- NCUEREC-112-009
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Exercise, Physical Activity Levels, Sleep Quality and Cognitive Function Among Older Adults.
- ClinicalTrials.gov ID
- NCT05834322
- Acronym / sponsor ID
- NCUEREC-112-009
- Conditions
- Cognitive Function
- Keywords
- physical activity, cognitive function, sleep, older adults
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Changhua University of EducationUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants should be over 65 and haven't been diagnosed with MCI or dementia.
Key inclusion criteria (3 listed)
- aged above 65
- haven't been diagnosed with MCI or dementia
- be able to read and write in Chinese
Key exclusion criteria (1 listed)
- elders who unable to talk or communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive function
Time frame: at the time the participants enroll
Chinese version of Montreal Cognitive Assessment (MoCA) will be use to assess cognitive function
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Function, run by National Changhua University of Education at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsuan Lee (+886975690234, xuanyolee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: at the time the participants enroll). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.