UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056732 |
|---|---|
| Receipt number | R000064839 |
| Scientific Title | Effectiveness of Health Education on Physical Activity to Increase Muscle Mass, Muscle Strength, and Physical Function in Young Women: A Preliminary Study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/16 12:04:05 |
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Basic information
Public title
Effectiveness of Health Education on Physical Activity to Increase Muscle Mass, Muscle Strength, and Physical Function in Young Women: A Preliminary Study
Acronym
Effectiveness of Health Education on Physical Activity to Increase Muscle Mass, Muscle Strength, and Physical Function in Young Women: A Preliminary Study
Scientific Title
Effectiveness of Health Education on Physical Activity to Increase Muscle Mass, Muscle Strength, and Physical Function in Young Women: A Preliminary Study
Scientific Title:Acronym
Effectiveness of Health Education on Physical Activity to Increase Muscle Mass, Muscle Strength, and Physical Function in Young Women: A Preliminary Study
Region
| Japan |
Condition
Condition
young women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of health education ((1) increase in physical activity, (2) continuation of physical activity, (3) increase in muscle mass, muscle strength, and physical function, and activation of autonomic nervous system activity) in young women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle mass
Muscle strength
Physical function
Key secondary outcomes
Physical activity
Exercise self-efficacy
Exercise Transformation Stage
Physical activity decision-making balance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1 Provide knowledge about physical activity and muscles
2 Individual consultation:Self check sheet,Review of physical activity practices by setting goals,Evaluation after practicing the physical activity set
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Female undergraduate and graduate students who are free of diseases of the circulatory system such as arrhythmia and hypertension, endocrine system such as thyroid disease and diabetes, and locomotor system of the trunk and lower limbs, and who do not have any diseases that interfere with daily living activities. In addition, they must not be taking any oral medications such as drugs for diabetes, hypertension, diuretics, anticoagulants, antiplatelet agents, or dyslipidemia.
Key exclusion criteria
If the selection criteria are not met
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Moe |
| Middle name | |
| Last name | Adachi |
Organization
Doshisha Women's College of liberal Arts
Division name
Department of Nursing, Faculty of Nursing
Zip code
610-0395
Address
97-1 Koudo Minami Hokodate, Kyotanabe City, Kyoto, Japan
TEL
0774-65-8818
ik21101@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Moe |
| Middle name | |
| Last name | Adachi |
Organization
Doshisha Women's College of liberal Arts
Division name
Department of Nursing, Faculty of Nursing
Zip code
610-0395
Address
97-1 Koudo Minami Hokodate, Kyotanabe City, Kyoto, Japan
TEL
0774-85-8818
Homepage URL
ik21101@dwc.doshisha.ac.jp
Sponsor or person
Institute
Doshisha Women's College of liberal Arts
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Doshisha Women's College of liberal Arts
Address
97-1 Koudo Minami Hokodate, Kyotanabe City, Kyoto, Japan
Tel
0774-65-8679
research@dwc.doshisha.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
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064839
