Alzheimer DiseaseNCT02978768
Tai Chi 6-Form Sports Apparatus With Alzheimer's Disease
A study testing Exercise, Computer-based cognitive training and Physico-Mental rehabilitation Wii in people with Alzheimer Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 59 to 92 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Exercise, Computer-based cognitive training and Physico-Mental rehabilitation Wii
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jun 2015
- 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 59 to 92 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild and Moderate Alzheimer's Disease(AD) participants.
Who cannot join
- Pacemaker patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Practice of Tai Chi 6-Form Sports Apparatus and Mental Training on Cognition, Self Care, Mood and General Health in Patients With Mild and Moderate Alzheimer's Disease: a Prospective Study.
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.
Read the detailed 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.
- 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.
- 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.
- 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.
- Conditions
- Alzheimer Disease
- Being tested
- Exercise, Computer-based cognitive training, Physico-Mental rehabilitation Wii
- Keywords
- dementia, Tai Chi, mental training, cognitive rehabilitation
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Physico-Mental rehabilitation Wii |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice May-Kuen Wong, Chang Gung Memorial Hospital
- Investigators
- Alice M Wong, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978768
- Sponsor's protocol ID
- 99-3780B
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Practice of Tai Chi 6-Form Sports Apparatus and Mental Training on Cognition, Self Care, Mood and General Health in Patients With Mild and Moderate Alzheimer's Disease: a Prospective Study.
- ClinicalTrials.gov ID
- NCT02978768
- Acronym / sponsor ID
- 99-3780B
- Conditions
- Alzheimer Disease
- Keywords
- dementia, Tai Chi, mental training, cognitive rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
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.
Detailed 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.
- 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.
- 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.
- 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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseFirst 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. |
| Cognitive training | Experimental | Device: Computer-based cognitive trainingSecond 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 training | Experimental | Device: Physico-Mental rehabilitation WiiThird 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. |
Who may qualify
- Ages
- 59 to 92 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild and Moderate Alzheimer's Disease(AD) participants.
Key exclusion criteria (1 listed)
- Pacemaker patients.
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 |
|---|---|---|
| ExerciseFirst 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 |
| Computer-based cognitive trainingSecond 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 | Cognitive training |
| Physico-Mental rehabilitation WiiThird 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 training |
Primary outcome
Balance
Time frame: Up to 3 year
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.
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 12 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Alice M Wong, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Computer-based cognitive training and Physico-Mental rehabilitation Wii in people with Alzheimer Disease, run by Chang Gung Memorial Hospital 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 12 Dec 2016. 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?
Balance (time frame: Up to 3 year). 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 12 Dec 2016.