UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047832 |
|---|---|
| Receipt number | R000054529 |
| Scientific Title | The Effects of a Home-based Multicomponent Lower Extremity Training Technique and Self-Efficacy for Exercise on Physical Function in Healthy Older Adults |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2023/03/31 16:36:33 |
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Basic information
Public title
The Effects of a Home-based Multicomponent Lower Extremity Training Technique and Self-Efficacy for Exercise on Physical Function in Healthy Older Adults
Acronym
The Effects of a Home-based Multicomponent Lower Extremity Training Technique and Self-Efficacy for Exercise on Physical Function in Healthy Older Adults
Scientific Title
The Effects of a Home-based Multicomponent Lower Extremity Training Technique and Self-Efficacy for Exercise on Physical Function in Healthy Older Adults
Scientific Title:Acronym
The Effects of a Home-based Multicomponent Lower Extremity Training Technique and Self-Efficacy for Exercise on Physical Function in Healthy Older Adults
Region
| Japan |
Condition
Condition
healthy older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of a home-based exercise program on physical function in older adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of exercise self-efficacy / baseline, after 12 weeks
Key secondary outcomes
The Japanese version of Physical Activity Scale for the Elderly, grip strength, knee extension strength, sit and reach test, Short Physical Performance Battery, the 25-question Geriatric Locomotive Function Scale, the stand-up test, the two-step test, the Timed Up and Go test, body composition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Multi-component lower extremity training (home-based exercise for 12 weeks) / Intervention
Interventions/Control_2
stretching exercise for 12 weeks monthly / control
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) the ability to perform activities of daily living without assistance
(2) persons with independent mobility (Barthel Index mobility score > 10)
Key exclusion criteria
(1) suspected cognitive impairment (mini-mental state test < 23 (full score 30)) and (2) serious illness (unstable cardiovascular disease, stroke, severe respiratory impairment, Parkinson's disease, diabetic peripheral neuropathy, or rheumatoid/arthritis)
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hungu |
| Middle name | |
| Last name | Jung |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL
082-424-6585
jung@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hungu |
| Middle name | |
| Last name | Jung |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima City, Hiroshima
TEL
082-424-6317
Homepage URL
jung@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Graduate School of Humanities and Social Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Hiroshima University
Address
Graduate School of Humanities and Social Sciences
Tel
082-424-6318
koudou@hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 30 | 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
| 2022 | Year | 01 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054529
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
