UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052727 |
|---|---|
| Receipt number | R000058307 |
| Scientific Title | Effects of Tai Chi training on changes |
| Date of disclosure of the study information | 2023/11/13 |
| Last modified on | 2024/11/07 09:11:19 |
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Basic information
Public title
Effects of Tai Chi training on changes in pain-related indicators in community dewelling older adults
Acronym
Effects of Tai Chi on pain in older adults
Scientific Title
Effects of Tai Chi training on changes
Scientific Title:Acronym
Effects of Tai Chi training on changes in pain-related indicators in community dewelling older adults
Region
| Japan |
Condition
Condition
Chronic pain
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of tai chi on physical pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Pain evaluation: Pain-related questionnaire PainDETECT (location of pain, degree of pain, course of pain, how pain is perceived), Tampa Scale for Kinesiophobia Japanese Version (TSK-J), pain catastrophizing Scale Japanese Version (PCS-J), Central Sensitization Inventory Japanese Version (CSI-J), pain disability assessment scale (PDAS) and quantitative sensory testing (QST): Pressure pain threshold, PPT
Key secondary outcomes
Physical frailty: grip strength, combined movements (TUG), balance ability (CROSSTEST), 5m walk test, body composition
Life habit, Health Status
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Tai chi training+Resistance training
Interventions/Control_2
Resistance training
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people with chronic pain
60-85 years old
Independent in activities of daily living
Key exclusion criteria
People who have a serious underlying disease, e.g. serious heart disease, kidney disease, etc.
People who have severe cognitive, speech, or hearing impairments
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Arts and Science
Zip code
819-0395
Address
No.744, Motooka, Nishi Ku, Fukuoka, Japan
TEL
0928026071
kishimoto@artsci.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyushu University
Division name
Faculty of Art and Science
Zip code
819-0395
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
TEL
0928026071
Homepage URL
kishimoto@artsci.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Hiro Kishimoto
Funding Source
Organization
Nippon Life Insurance Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Health Sciences and Counseling Center Joint Ethics Committee
Address
No.744, Motooka, Nishi-ku, Fukuoka, Japan
Tel
0928025881
kishimoto@artsci.kyushu-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
九州大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 13 | 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
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
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 08 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058307
