UMIN-CTR Clinical Trial

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
Email	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
Email	tyoda@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki University of Medical Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052529