NCT05353920

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
Last Updated

May 6, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

December 14, 2017

Last Update Submit

April 30, 2022

Conditions

Cognitive Function 1, Social

Outcome Measures

Primary Outcomes (2)

  • MMSE

    cognitive function

    12 weeks

  • MoCA

    cognitive function

    12 weeks

Study Arms (2)

Cognitive traiinig

EXPERIMENTAL
Other: Cognitive training

Active control

ACTIVE COMPARATOR
Other: Cognitive training

Interventions

Cognitive trainingOTHER

cognitive related training bu virtual reality system

Active controlCognitive traiinig

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years old

You may not qualify if:

  • TBI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TMU

Taipei, Taiwan

Location

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kuei-ru Chou

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 14, 2017

First Posted

April 29, 2022

Study Start

December 1, 2017

Primary Completion

April 1, 2019

Study Completion

April 8, 2019

Last Updated

May 6, 2022

Record last verified: 2022-04

Locations

TW(1)