UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038221
Receipt No. 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

* 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 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
Email 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
Email morikouhei1@gmail.com

Sponsor
Institute Kansai University of Welfare Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043336

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.