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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02978768
Other study ID # 99-3780B
Secondary ID
Status Completed
Phase N/A
First received November 29, 2016
Last updated December 8, 2016
Start date August 2011
Est. completion date June 2015

Study information

Verified date December 2016
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: National Science Council
Study type Interventional

Clinical Trial 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.


Description:

According to statistics in Taiwan, two to four percent the elderly of aged more than 65 years old have dementia. As the decreasing birth rate and the advancement of medical care making life expectancy getting longer, the society in Taiwan is aging with a fast pace, leading to a tremendous increase of patients suffering dementia. Many studies have shown that Tai Chi Chuan can improve quality of life, cardiopulmonary function, pain control, mentality, endurance, flexibility, balance, can decrease the possibility of incidental, and enhance immunity and sleep quality in the elderly. Many studies showed that higher physical activity or mental training is associated with reduced risk for Alzheimer Disease. However, Tai Chi Chuan could be a little difficult for elderly people with dementia because they can't remember so that the investigators have designed Tai Chi 6-Form sports apparatus and the clinical trial was done for health and stroke elderly people. Also, the investigators have developed a mental training program for patients with Alzheimer Disease. 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.

1. Study aims during the first year: the investigators investigate the effect of Tai Chi 6-Form accompanied with music rhythm for patients with dementia to remember in behavioral and general health, functional and cognitive decline as well as family caregiver's satisfaction, the use of health care services, and recommendation for other people among patients with mild and moderate Alzheimer Disease.

2. Study aims during the second year: the investigators investigate the effect of mental training with computer mind training games on behavioral and general health, functional and cognitive decline as well as the use of health care services and family caregiver's satisfaction and recom mendation for other people among patients with mild and moderate Alzheimer Disease.

3. Study aims during the third year: the investigators investigate the effect of tele-Tai Chi 6-Form and mental training on line which are to combine to physico-mental rehabilitation Wii (PM Wii) on behavioral and general health, functional and cognitive decline as well as the use of health care services and family caregiver's satisfaction and recommendation for other people among patients with mild and moderate Alzheimer Disease. According to Tai Chi 6-Form, the investigators will develop the software to watch Tai Chi 6-Form exercise on computer on line. The patient can copy Tai Chi 6-Form movement accompanied with previous music rhythm at home. Therefore, Tai Chi 6-Form and mental training which are a great benefit to patients with dementia will be popular at home or in the community. Patients with dementia return back to the community.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 59 Years to 92 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Pacemaker patients.

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Exercise
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.
Device:
Computer-based cognitive training
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.
Physico-Mental rehabilitation Wii
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.

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital TaoYuan county

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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