NCT02978768

Brief Summary

The objective of the present project is to develop complementary and alternative medicine (CAM) for The Chang Gung Dementia Center to alleviate the symptoms and signs of patients with Alzheimer Disease, an approach aiming at decreasing the burden on family, society and nation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable alzheimer-disease

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

3.8 years

First QC Date

November 29, 2016

Last Update Submit

December 8, 2016

Conditions

Alzheimer Disease

Keywords

dementiaTai Chimental trainingcognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Balance

    Outcome measures showed that mild and moderate AD participants received 12-week Tai Chi 6-Form exercise training can improved at balance score, and 12-week computer-based cognitive training may be able to improve their ability to understand instructions and reflected in task execution. In this study, 12-week PM Wii shows no significant difference at balance performance or cognitive function, probably due to the insufficient training intensity and lack of sensory feedback. However, tele-care system is the development trends in the future undoubtedly.

    Up to 3 year

Study Arms (3)

Exercise

EXPERIMENTAL

First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Other: Exercise

Cognitive training

EXPERIMENTAL

Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Device: Computer-based cognitive training

Physico-Mental training

EXPERIMENTAL

Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Device: Physico-Mental rehabilitation Wii

Interventions

ExerciseOTHER

First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Exercise
Computer-based cognitive trainingDEVICE

Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Cognitive training
Physico-Mental rehabilitation WiiDEVICE

Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.

Physico-Mental training

Eligibility Criteria

Age59 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mild and Moderate Alzheimer's Disease(AD) participants.

You may not qualify if:

  • Pacemaker patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alice M Wong, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

August 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 12, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)