UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038221 |
|---|---|
| Receipt number | R000043336 |
| Scientific Title | Verification of long-term intervention effect of Tai Chi Yuttari-exercise for prevention of arteriosclerosis and improvement of physical function in community-dwelling elderly |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2021/06/08 12:38:37 |
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Basic information
Public title
Verification of long-term intervention effect of Tai Chi Yuttari-exercise for prevention of arteriosclerosis and improvement of physical function in community-dwelling elderly
Acronym
Verification of long-term intervention effect of Tai Chi Yuttari-exercise for prevention of arteriosclerosis and improvement of physical function in community-dwelling elderly
Scientific Title
Verification of long-term intervention effect of Tai Chi Yuttari-exercise for prevention of arteriosclerosis and improvement of physical function in community-dwelling elderly
Scientific Title:Acronym
Verification of long-term intervention effect of Tai Chi Yuttari-exercise for prevention of arteriosclerosis and improvement of physical function in community-dwelling elderly
Region
| Japan |
Condition
Condition
Disuse syndrome
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of practicing Tai Chi Yuttari-exercise for 1 year on arteriosclerosis status and physical functioning of community-dwelling older people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Term for evaluation
At baseline, at 6 months, and at 1 year
Evaluation items
1.Vascular function: cardio ankle vascular index (CABI)
2.Physical function: hand grip strength, knee extension force, trunk anteflexion, one-leg balance with open eyes, functional reach test, gait speed(10m), timed up and go test.
Key secondary outcomes
Term for evaluation
At baseline, at 6 months, and at 1 year
Evaluation items
1.The frequency of participation; practice of the exercise at home
2.Exercise habits
3.Waist circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention group was divided into two sub-groups, that participated in Tai Chi Yuttari-exercise classes for a 1-year period, either from January to December 2012, or from April 2012 to March 2013. The Tai Chi Yuttari-exercise classes were held once weekly for the first 3 months, and twice weekly during the 9-month period from April to December. A standard Tai Chi Yuttari-exercise class lasted for 60 minutes, with the first 10 minutes comprising preparatory exercises; the next 20 minutes were spent practicing the sitting version, followed by a 10-minute resting period. The final 20 minutes were spent practicing the standing version. The participants were also provided videos of the Tai Chi Yuttari-exercises and a pamphlet to take home, and were instructed to practice Tai Chi Yuttari-exercise at home, once a week. They were informed that each Tai Chi Yuttari-exercise practice session should last for at least 30 minutes, and that they were free to select either the sitting or standing version.
Interventions/Control_2
The control group underwent baseline measurements in April 2014. Subsequent measurements at 6 months and 1 year follow-up, were performed in October 2014 and in March 2015, respectively.
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
100
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Mori |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code
5820026
Address
11-1, Asahigaoka, 3-chome, Kashiwara, Osaka 582-0026, JAPAN
TEL
0729780088
morikouhei1@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Mori |
Organization
Kansai University of Welfare Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Allied Health Sciences
Zip code
5820026
Address
11-1, Asahigaoka, 3-chome, Kashiwara, Osaka 582-0026, JAPAN
TEL
072-978-0088
Homepage URL
morikouhei1@gmail.com
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Welfare Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Welfare Sciences
Address
11-1, Asahigaoka, 3-chome, Kashiwara, Osaka 582-0026, JAPAN
Tel
0729780088
morikouhei1@gmail.com
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
| 2019 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/abs/pii/S0167494320300042?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S0167494320300042?via%3Dihub
Number of participants that the trial has enrolled
89
Results
The mean cardio-ankle vascular index improved significantly from 8.44 at baseline to 8.20 after 6 months in the intervention group;
however, no significant difference was observed at 1 year. Conversely, compared with baseline, the functional reach, gait speed, and timed up-and-go test results improved significantly after 6 months in this group; these improvements were maintained after 1 year. No significant changes in arteriosclerosis or physical function were observed in the control group.
Results date posted
| 2021 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The intervention group comprised older people aged 60 yearsnd older, living near the Kansai University of Welfare Sciences, who had participated in an advanced information session on Tai Chi Yuttari-exercise held in December 2011, and had consented to participate in the study. The control group also comprised people aged 60 years and older living near the Kansai University of Welfare Sciences, who had consented to participate in the study.
Participant flow
The intervention group comprised 45 individuals who participated in exercise classes for 1 year, and underwent measurements of vascular and physical function; the control group comprised 44 individuals who underwent measurements of vascular and physical function at the same time points as the members of the intervention group.
Adverse events
non
Outcome measures
Cardio-ankle vascular index, Physical function, Practice of the exercises at home by members of the intervention group and risk events
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
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043336
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