UMIN-CTR Clinical Trial

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 Short Physical Performance Battery, SPPB Quality of Life in Alzheimers Disease, QOL-AD Baseline characteristics (age, gender, marriage, educational background)
Key secondary outcomes

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
Institution consideration
Blocking
Concealment

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
Email	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
Email	176k056k@stu.kobe-u.ac.jp

Sponsor
Institute	Kobe University, Graduate School of Health Sciences
Institute
Department

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
Email	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

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
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	Preinitiation
Date of protocol fixation	2020 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 08 Day
Last modified on	2020 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047982

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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