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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name