UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006991 |
|---|---|
| Receipt number | 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 20:45:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tnomura@tamateyama.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
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
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
Value
https://center6.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 |
