UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057660 |
|---|---|
| Receipt number | R000057045 |
| Scientific Title | Effects of Exercise Guidance through Care Prevention Supporters on Elderly People Living in the Community -Effects of Pelvic Floor Muscle Group Training Instruction- |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/20 11:55:51 |
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Basic information
Public title
Effects of Exercise Guidance through Care Prevention Supporters on Elderly People Living in the Community
-Effects of Pelvic Floor Muscle Group Training Instruction-
Acronym
Effects of Exercise Guidance through Care Prevention Supporters on Elderly People Living in the Community
Scientific Title
Effects of Exercise Guidance through Care Prevention Supporters on Elderly People Living in the Community
-Effects of Pelvic Floor Muscle Group Training Instruction-
Scientific Title:Acronym
Effects of Exercise Guidance through Care Prevention Supporters on Elderly People Living in the Community
Region
| Japan |
Condition
Condition
Elderly people living in the community
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the impact of supporter-mediated exercise instruction on older adults living in the community.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Age, length, weight, BMI, number of births, general exercise habits, number of days of exercise, differentiation of the state of care, grip strength, Timed Up and Go Test (TUG), internal rotational strength of the femoral joints, standing position of the feet, International Consultation on Incontinence Questionnaire incontinence symptoms and QOL evaluation, life space assessment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Duration of intervention: 2 months
Amount of intervention: The participants were instructed to perform pelvic floor muscle group training at home three times a week for 10 minutes per session.
Intervention details: Pelvic floor muscle group training was performed using a combination of the pelvic floor muscle group training method of Kim et al. and training using a towel as reported by Countryside. The pelvic floor muscle group training by Kim et al. consists of 8 to 10 short contractions and relaxations of 2 to 3 seconds, followed by 10 contractions of 6 to 8 seconds followed by 10 seconds of relaxation, which strengthens fast and slow muscles. In the pelvic floor muscle group training by Countryside et al., a rolled towel is placed on the pubic area in a chair-sitting position, and the user is asked to pull up the towel.
Interventions/Control_2
Intervention period: 2 months
Amount of intervention: The participants were instructed to perform the training at home three times a week for 10 minutes per session, which they usually perform at the meeting place.
Intervention content: The participants were instructed to perform the training they usually perform at home three times a week at home.
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
| 110 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Elderly residents of Ukiha City who participate in community gatherings
(2) Those who have signed a consent form after understanding the explanation of research cooperation.
(3) Persons whose physical sex is female.
Key exclusion criteria
(1) Those who could not give consent for this study
(2) Those who are unable to perform pelvic floor muscle group training
(3) Those whose physical sex is male.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Harano |
Organization
Our Lady of the Snow,Social Medical Corporation
Division name
Community Involvement Center
Zip code
830-8543
Address
422 Tsubuku Honmachi, Kurume City, Fukuoka Prefecture
TEL
0942-35-3322
t.harano.411pt@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Harano |
Organization
Our Lady of the Snow,Social Medical Corporation
Division name
Community Involvement Center
Zip code
830-8543
Address
422 Tsubuku Honmachi, Kurume City, Fukuoka Prefecture
TEL
0942-35-3322
Homepage URL
t.harano.411pt@gmail.com
Sponsor or person
Institute
Social Medical Corporation Our Lady of Snow (St. Mary's Research Center)
Institute
Department
Personal name
Funding Source
Organization
Social Medical Corporation Our Lady of Snow (St. Mary's Research Center)
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
Our Lady of the Snow,Social Medical Corporation
Address
422 Tsubuku Honmachi, Kurume City, Fukuoka Prefecture
Tel
0942-35-3322
t.harano.411pt@gmial.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 25 | 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
28
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 | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057045
