Cognitive Function 1, SocialNCT05353920
The Effect of Cognitive Function Training Program for Community Elderly
A study testing Cognitive training in people with Cognitive Function 1, Social, run by Huie-Ling Chiu at 1 site in Taiwan.
Trial summary
Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated. Objective. 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 1, Social
- What is being tested?
- Cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2017to 8 Apr 2019
- Phase
- Interventional
- 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
Who may be able to join
- 65 years old
Who cannot join
- TBI
Trial locations and contacts
1 site in 1 country.
About this study
Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated.
Objective. The purpose of this study is to construct and evaluate the effects of cognitive function training program on cognitive function for community elderly.
Read more
Design. This is a randomized controlled study. Study subjects are elderly living in community. Subjects will be randomized into experimental group or active control group. The evaluation of the program will be evaluated at baseline, immediate after, 3 months, 6 months, and 1 year after the last session. The primary outcome indicators of the training is cognitive function, assessed by MMSE and MoCA.
Expected contribution. With rigorous design and long term follow-up, the effectiveness of cognitive function training program in Chinese population in Taiwan can be evaluated. Results of the current study will determine the value of the cognitive function training program and provide valuable information for future utilization of this protocol.
- Conditions
- Cognitive Function 1, Social
- Being tested
- Cognitive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
cognitive related training bu virtual reality system
| Study group | Role | What they receive |
|---|---|---|
| Cognitive traiinig | Experimental | Not described Receives: Other: Cognitive training |
| Active control | Active comparator | Not described Receives: Other: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
cognitive function
Measured: 12 weeks
MoCA
cognitive function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Dec 2017
- Primary completion1 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function 1, SocialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huie-Ling Chiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huie-Ling Chiu, Taipei Medical University
- Investigators
- Kuei-ru Chou, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353920
- Sponsor's protocol ID
- N201704031
- Status last verified
- Apr 2022
- First submitted
- 14 Dec 2017
- Last updated
- 6 May 2022
- Results posted
- 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Function Training Program for Community Elderly
- ClinicalTrials.gov ID
- NCT05353920
- Acronym / sponsor ID
- N201704031
- Conditions
- Cognitive Function 1, Social
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Huie-Ling ChiuUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 29 Apr 2022 (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.
Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated.
Objective. The purpose of this study is to construct and evaluate the effects of cognitive function training program on cognitive function for community elderly.
Design. This is a randomized controlled study. Study subjects are elderly living in community. Subjects will be randomized into experimental group or active control group. The evaluation of the program will be evaluated at baseline, immediate after, 3 months, 6 months, and 1 year after the last session. The primary outcome indicators of the training is cognitive function, assessed by MMSE and MoCA.
Expected contribution. With rigorous design and long term follow-up, the effectiveness of cognitive function training program in Chinese population in Taiwan can be evaluated. Results of the current study will determine the value of the cognitive function training program and provide valuable information for future utilization of this protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive traiinig | Experimental | Other: Cognitive training |
| Active control | Active comparator | Other: Cognitive training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years old
Key exclusion criteria (1 listed)
- TBI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingcognitive related training bu virtual reality system | Other | Active control, Cognitive traiinig |
Primary outcome
MMSE
Time frame: 12 weeks
cognitive function
MoCA
Time frame: 12 weeks
cognitive function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Cognitive Function 1, Social
RecruitingObservational study
Socio-cognitive and Biological Responses to Maltreatment
Bipolar 1 Disorder, Control Subjects
Not yet recruiting
The Effect of ACT-Based Nursing Interventions on Social Cognition, Emotion Regulation and Psychological Flexibility in Patients With Schizophrenia
SCHIZOPHRENIA 1 (Disorder)
Recruiting
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia
Narcolepsy, Social Cognition
Recruiting
Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways
SCHIZOPHRENIA 1 (Disorder), Schizo Affective Disorder
Active, not recruiting
Effect of Moringa Royal Jelly on the Nutritional Status and Cognitive Level of Adolescent Girls
Undernutrition, Anemia
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.
Kuei-ru Chou principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training in people with Cognitive Function 1, Social, run by Huie-Ling Chiu 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 1 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: finished, as of the sponsor's last update on 6 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMSE (time frame: 12 weeks). The study lists 2 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 6 May 2022.