UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046042 |
|---|---|
| Receipt number | R000052529 |
| Scientific Title | A study on the preventive effect of exercise intervention on sarcopenia in Thai older people |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/11/11 14:00:20 |
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Basic information
Public title
A study on the preventive effect of exercise intervention on sarcopenia in Thai older people
Acronym
Exercise effectiveness of sarcopenia prevention for Thai older people
Scientific Title
A study on the preventive effect of exercise intervention on sarcopenia in Thai older people
Scientific Title:Acronym
Exercise effectiveness of sarcopenia prevention for Thai older people
Region
| Asia(except Japan) |
Condition
Condition
Sarcopenia
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is an interventional study to determine the effect of a single muscle mass maintenance training course on sarcopenia prevention and quality of life (QOL) in the older Thai people.
The purpose of this study is to clarify the extent to which a single, simple, and self-sustainable training intervention by a health and exercise instructor can lead to the prevention of sarcopenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference between the mean values of the intervention and control groups for grip strength, skeletal muscle mass index (SMI), and 6 m walking speed after 24 weeks of exercise intervention.
Key secondary outcomes
Differences in the QOL rating scale (SF-8) between groups after 24 weeks of exercise intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Simple exercises (stretching while grasping the back of a chair, thigh and heel lift exercises) that can be done continuously every day were taught.
Intervention instruction was given for one hour at the first session. After that, the intervention group was asked to record their exercise performance every day. Initial measurement items were measured again after 24 weeks.
Interventions/Control_2
After the initial measurement of muscle mass and grip strength, the participants were asked to lead a normal life and the initial measurement items were measured again after 24 weeks.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Able to walk to the venue on his/her own.
Able to read, write, and give instructions through conversation.
Key exclusion criteria
Systolic blood pressure 180 mmHg or higher
Diastolic blood pressure of 110 mmHg or more
Persons who are prohibited from exercising by a physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoda |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Health and Sports Science
Zip code
701-0193
Address
288, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
tyoda@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yoda |
Organization
Kawasaki University of Medical Welfare
Division name
Department of Health and Sports Science
Zip code
701-0193
Address
288, Matsushima, Kurashiki city, Okayama
TEL
086-462-1111
Homepage URL
tyoda@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki University of Medical Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Faculty of Medicine, Chiang Mai University
Name of secondary funder(s)
Kawasaki University of Medical Welfare
IRB Contact (For public release)
Organization
Kawasaki University of Medical Welfare
Address
288, Matsushima, Kurashiki city, Okayama
Tel
086-462-1111
tyoda@med.kawasaki-m.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 11 | 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
61
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
| 2019 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 08 | 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
| 2021 | Year | 11 | Month | 11 | Day |
Last modified on
| 2021 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052529
