UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050290 |
|---|---|
| Receipt number | R000057266 |
| Scientific Title | Examination of muscle hypertrophy effect for community-dwelling elderly people by implementing a specialized exercise program |
| Date of disclosure of the study information | 2023/02/19 |
| Last modified on | 2023/05/03 09:26:14 |
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Basic information
Public title
Examination of muscle hypertrophy effect for community-dwelling elderly people by implementing a specialized exercise program
Acronym
Examination of muscle hypertrophy effect for community-dwelling elderly people by implementing a specialized exercise program
Scientific Title
Examination of muscle hypertrophy effect for community-dwelling elderly people by implementing a specialized exercise program
Scientific Title:Acronym
Examination of muscle hypertrophy effect for community-dwelling elderly people by implementing a specialized exercise program
Region
| Japan |
Condition
Condition
community-dwelling elderly
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of skeletal muscle hypertrophy effect by exercise intervention for community-dwelling elderly people
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle hypertrophy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exercise
Method: Resistance exercise (squats: 10 reps x 3 sets) and balance exercise (single leg stand: 1 minute each for left and right x 3 sets)
Frequency: 3 or more times a week/day
Time: 15 minutes/day
Interventions/Control_2
non-exercise
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects who can continue to carry an accelerometer during the study period (12 weeks) during daily activities
2) Community-dwelling elderly aged 65 to 75 (age at study registration)
3) Persons who can freely watch YouTube (video) playback at their own discretion (regardless of place, time, etc.) by owning a smartphone.
4) Those who can operate to the extent that they can play YouTube using a smartphone
5) Those who have an individual (family) contract for the amount of communication that can play about 15 minutes of video per day (including home WIFI equipment)
Key exclusion criteria
1) Persons certified as needing long-term care or support under long-term care insurance
2) Subjects who are suspected of having cognitive decline (by prior implementation of MMSE research)
3) Persons who are unable to walk independently and whose activities of daily living are restricted by doctors (e.g., wheelchair users, walking aids such as T-shaped canes)
4) Subjects who have a habit of exercising (exercising for 30 minutes or more a day at least twice a week for at least 1 year)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3050044
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
0298533795
minaminagasaki2007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | yasuhiro |
| Middle name | |
| Last name | suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Rehabilitation Medicine
Zip code
3050044
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
0298533795
Homepage URL
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Department of Rehabilitation Medicine, University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
0298533795
minaminagasaki2007@yahoo.co.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
| 2023 | Year | 02 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2033 | Year | 12 | 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
| 2023 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057266
| Research Plan | |
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| 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 |
