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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006991
Receipt No. R000008226
Scientific Title Effect of a Tai Chi Yuttari-exercise program for the prevention of conditions requiring long-term care in community-dwelling elderly
Date of disclosure of the study information 2012/01/01
Last modified on 2019/09/30

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Basic information
Public title Effect of a Tai Chi Yuttari-exercise program for the prevention of conditions requiring long-term care in community-dwelling elderly
Acronym Tai Chi Yuttari-exercise regimen for the prevention of conditions requiring long-term care (Tai Chi care)
Scientific Title Effect of a Tai Chi Yuttari-exercise program for the prevention of conditions requiring long-term care in community-dwelling elderly
Scientific Title:Acronym Tai Chi Yuttari-exercise regimen for the prevention of conditions requiring long-term care (Tai Chi care)
Region
Japan

Condition
Condition Disuse syndrome
Classification by specialty
Rehabilitation medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the comprehensive effects (physical, psychological and behavioral effects) of the Tai Chi Yuttari-exercise available to practice at home by the community-dwelling elderly.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Term for evaluation
Pre, during and post intervention; follow-up, 12-month

Evaluation items
1.Physical function and physical ability: grasping power, knee extension force, trunk anteflexion, gait speed, time for single leg balance with open or closed eyes, timed up & go test, functional reach test, time for standing from long-sitting position
2.Vascular endothelial function: cardio ankle vascular index (CABI), ankle brachial pressure index (ABI)
3.Health-related quality of life: SF-36
Key secondary outcomes Term for evaluation
Pre, during and post intervention; follow-up, 12-month

Evaluation items
1.The frequency of participation; practice of the exercise at home
2.Body composition
3.Abdominal circumference
4.Physical activity self-efficacy
5.Daily activity ability: Metropolitan Institute of Gerontology index of competence

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The first-intervention group participated in the Tai Chi Yuttari-exercise once a week for 3 months from January to March 2012. Next, they participated in exercises twice a week for 9 months from April to December 2012. Each session lasted 90 min including a break to drink water. Moreover, behavioral approach to practice the Tai chi-Yuttari exercise at home was provided using a printed booklet, DVD or Video of the exercise program.
Interventions/Control_2 The second-intervention group participated in the Tai Chi Yuttari-exercise once a week for 3 months from April to June 2012. Next, they participated in exercise programs twice a week for 9 months from July 2012 to March 2013. Moreover, a behavioral approach to practice the Tai chi-Yuttari exercise at home was provided using a printed booklet, DVD or Video of the exercise. The same program was provided for the second-intervention group.
Interventions/Control_3
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The community-dwelling elderly aged 60 years and older.
Key exclusion criteria 1.Participants who could not adapt to the exercise
2.Independent walking is impossible
3.Significant limitations in their activities of daily of living
4.Severe heart and/or respiratory disease
5.Participants having acute and/or chronic orthopedic disease, and who were presently receiving medical treatment
6.Participants having a severe motor impairment of the upper/lower-extremities
7.Cerebrovascular or cardiovascular events reported within the past 6 months
8.Patients having severe infectious disease
9.Other conditions that resulted in the participants being considered to be ineligible based on the opinion of the researcher
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takuo
Middle name
Last name Nomura
Organization Kansai University of Welfare Sciences
Division name Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code 582-0026
Address 11-1, Asahigaoka, 3-chome, Kashiwara, Osaka 582-0026, Japan
TEL 072-978-0088
Email tnomura@tamateyama.ac.jp

Public contact
Name of contact person
1st name Takuo
Middle name
Last name Nomura
Organization Kansai University of Welfare Sciences
Division name Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code 582-0026
Address 3-11-1, Asahigaoka, Kashiwara, Osaka 582-0026, Japan
TEL 072-978-0088
Homepage URL
Email tnomura@tamateyama.ac.jp

Sponsor
Institute Kansai University of Welfare Sciences
Institute
Department

Funding Source
Organization Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai University of Welfare Sciences
Address 3-11-1, Asahigaoka, Kashiwara, Osaka 582-0026, Japan
Tel 072-978-0088
Email umin-kfk@tamateyama.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 関西福祉科学大学(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 01 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=
Publication of results Published

Result
URL related to results and publications http://researchmap.jp/physicaltherapy/Tai-Chi-Yuttari-exercise/
Number of participants that the trial has enrolled 47
Results
In the intervention group, subjects exercised for 2.9 times per week. In the intervention group, a statistically significant improvement was observed in CAVI (pre 8.52, post 8.24) and the grip strength (pre 27.5kgf, post 28.7kgf). There were no significant changes in the control group.
Results date posted
2019 Year 09 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-seven elderly people 60 years of age and over.
Participant flow
Participants were randomized to either an intervention group (n = 24) or a control group (n = 23).
Adverse events
None.
Outcome measures
The control group was not given any intervention. The cardio-ankle vascular index (CAVI), as an indicator of the arterial stiffness, physical compositions and physical functions were evaluated before and after the intervention period. We analyzed 46 people (24 people in the intervention group and 22 people in the control group) who could be followed up after three-month intervention.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 12 Month 27 Day
Date of IRB
2011 Year 12 Month 01 Day
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 06 Month 01 Day
Date trial data considered complete
2015 Year 07 Month 01 Day
Date analysis concluded
2015 Year 10 Month 01 Day

Other
Other related information 1) Nomura T, Akezaki Y, Mori K, Nakamata E, Asada F, Mori Y, Kai S, Watanabe M. Investigating the circulatory-respiratory response of elderly people during Tai Chi Yuttari-exercise. Health 5(12A): 58-63, 2013.

2) Mori K, Nomura T, Akezaki Y, Kataoka S, Nakamata E, Asada F, Mori Y, Kai S, Watanabe M: Does three months of Tai chi Yuttari-exercise improve the cardio-ankle vascular index? Randomized controlled trial. Res Exer Epidemiol 15(2): 71-80, 2013. (in Japanese).

3) Yamamoto S, Kagawa K, Hori N, Akezaki Y, Mori K, Nomura T. Preliminary validation of an exercise program suitable for pregnant women with abnormal glucose metabolism: inhibitory effects of Tai Chi Yuttari-exercise on plasma glucose elevation. J Phys Ther Sci 28(12): 3411-3415, 2016.

Management information
Registered date
2011 Year 12 Month 30 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008226

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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