The Effect of Cognitive Function Training Program for Com... | NCT05353920

Studies
The Effect of Cognitive Function Training Program for Community Elderly

NCT05353920

Sponsor

Huie-Ling Chiu

Status

Completed

Last Update Posted

May 6, 2022Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Cognitive Function 1, Social

Interventions

Cognitive training

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Apr 8, 2019Actual

First Submitted Date

Dec 14, 2017

First Submission Date that Met QC Criteria

Apr 28, 2022

First Posted Date

Apr 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2022

Last Update Posted Date

May 6, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Huie-Ling Chiu, Dr., Taipei Medical UniversitySponsor-Investigator

Lead Sponsor

Huie-Ling ChiuOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive traiinig	Experimental		Other: Cognitive training
Active control	Active Comparator		Other: Cognitive training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive training	Other	cognitive related training bu virtual reality system	Active control Cognitive traiinig

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MMSE	cognitive function	12 weeks
MoCA	cognitive function	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

65 years old

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kuei-ru Chou	Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TMU		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000091942	Cognitive Training

Ancestor Terms

ID	Term
D000066530	Neurological Rehabilitation
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided