UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042051 |
|---|---|
| Receipt number | R000047982 |
| Scientific Title | The effectiveness of Tai chi on the sleep, physical and mental health for the elderly with dementia: 3-Arm Randomized Controlled Trial |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2021/10/13 13:23:55 |
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Basic information
Public title
The effectiveness of Tai chi on the sleep, physical and mental health for the elderly with dementia
Acronym
The effectiveness of Tai chi on the sleep, physical and mental health for the elderly with dementia
Scientific Title
The effectiveness of Tai chi on the sleep, physical and mental health for the elderly with dementia: 3-Arm Randomized Controlled Trial
Scientific Title:Acronym
The effectiveness of Tai chi on the sleep, physical and mental health for the elderly with dementia
Region
| Asia(except Japan) |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct an exercise program using Tai Chi and conventional exercise for elderly people living in elderly facilities in China, and to verify the effects of each exercise therapy on physical and mental conditions such as sleep.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Objective sleep status measured by activity meter (ActiGraphGT9X+) or sleep scan to measure the sleep efficiency and activity
Short Physical Performance Battery, SPPB
Key secondary outcomes
Quality of Life in Alzheimers Disease, QOL-AD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The elderly with dementia who live in the facility, will be divided into three groups according by the randomized numerical table method: Tai Chi group, conventional exercise group, and control group, fo 12 weeks.
Tai Chi group: 8 Simple Tai Chi will be choosed, and one hour after breakfast, a professional instructor with more than five years of teaching experience or a qualification will teach the Type 8 Simple Tai Chi Movement in a group. Researchers and research assistants watch over the movement to ensure the safety of the elderly with dementia. Tai Chi intervention is performed three times a week for 50 minutes. Warm-up exercise for 5 minutes (turn the ankle and wrist, turn the waist, lightly loosen, such as flexion of the knee.) It is to expand the range of motion further while moving. From dynamic stretching to close to the movement of the main movement), Tai Chi is performed for 40 minutes. Adjust the range and strength you can to match the level of individual physical function and activity ability) and cool down exercise for 5 minutes (stretch slowly to loosen muscles. Stretch with the strength to be comfortable slowly without overdoing it. Stretch not only the lower body centered on the foot, but also the upper body.)
Interventions/Control_2
Conventional exercise group: 1 hour after breakfast, instructors with training guidance history of 5 years or more to teach conventional exercise, such as aerobic exercise in a group. Researchers and research assistants watch over the movement to ensure the safety of the elderly with dementia. Intervention by conventional motion is carried out three times a week for 50 minutes. Warm-up exercise for 5 minutes (same as Tai Chi group), conventional exercise such as aerobic exercise for 40 minutes, for the elderly, less burden, it is said that the effect of loosening the muscle and improvement of blood flow in a simple exercise can be expected. (The strength training performed sitting on a chair is done for 10 minutes, the strength training performed standing for 10 minutes, the radio gymnastics first and second for 10 minutes, and the walk according to the music for 10 minutes.) Adjust the range and intensity you can to match the level of individual physical function and activity ability), and perform a cooldown exercise for 5 minutes (same as Tai Chi group).
Interventions/Control_3
Control group: The research period is asked to continue the same life as usual without intervention. After the research is complete, the elderly are free to choose Tai Chi or conventional exercise and conduct it for 12 weeks.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who are 65 years of age or older and have a mild to moderate cognitive function, and those with 10 to 23 points of Mini-Mental State Experience (MMSE) who are judged by their doctors to be able to participate in exercise programs.
Condition is stable, pain, pruritus, itchy leg syndrome, those who do not admit symptoms that significantly inhibit sleep, such as sleep apnea syndrome.
Those who have not been contraindicated from their doctor for exercising.
Key exclusion criteria
Those who have serious acute or chronic diseases and have difficulty carrying out exercise.
Those who have regular exercise habits (3 times a week, 30 minutes each time, 3 months or more) in the last year.
Target sample size
93
Research contact person
Name of lead principal investigator
| 1st name | Chieko |
| Middle name | |
| Last name | Greiner |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
Tomogaoka, Suma-ku, Kobe 654-0142 Hyogo, JAPAN
TEL
078-796-4520
greiner@harbor.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Ran |
| Middle name | |
| Last name | Gao |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
Tomogaoka, Suma-ku, Kobe 654-0142 Hyogo, JAPAN
TEL
090-1572-3283
Homepage URL
176k056k@stu.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University, Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kobe University, Graduate School of Health Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University, Graduate School of Health Sciences
Address
Tomogaoka, Suma-ku, Kobe 654-0142 Hyogo, JAPAN
Tel
090-1572-3283
176k056k@stu.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
海南省老人ホーム
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
91
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047982
