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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000042051 |
Receipt No. | 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 | 2020/10/08 |
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 |
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Condition | ||
Condition | dementia | |
Classification by specialty |
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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.
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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 |
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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.) |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 93 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |