UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047774 |
|---|---|
| Receipt number | R000054464 |
| Scientific Title | Effects of resistance training on body composition and nutritional status in the elderly. |
| Date of disclosure of the study information | 2022/05/20 |
| Last modified on | 2024/05/20 11:07:05 |
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Basic information
Public title
Effects of resistance training on body composition, physical function, and nutritional status in the elderly.
Acronym
Effects of resistance training on body composition, physical function, and nutritional status in the elderly.
Scientific Title
Effects of resistance training on body composition and nutritional status in the elderly.
Scientific Title:Acronym
Effects of resistance training on body composition and nutritional status in the elderly.
Region
| Japan |
Condition
Condition
Undernutrition, sarcopenia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improved body composition and nutritional status
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Muscle mass
Key secondary outcomes
blood albumin, blood total cholesterol, blood lymphocyte count, CONUT, GNRI, energy intake
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Orthostatic training 60 times a day, 3 days a week, for a total of 4 months: 2 months of training and 2 months of suspension.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Able to stand independently or with assistance.
Key exclusion criteria
Poor general condition
Difficulty standing up
Difficulty following instructions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YOSHIZAWA |
| Middle name | |
| Last name | KENJI |
Organization
Osaka Medical and Pharmaceutical University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-684-7237
genius_intend@yahoo.co.jp
Public contact
Name of contact person
| 1st name | YOSHIZAWA |
| Middle name | |
| Last name | KENJI |
Organization
Osaka Medical and Pharmaceutical University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-684-7237
Homepage URL
genius_intend@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Graduate School of Medicine Department of Rehabilitation Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
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
Higashi Osaka Co-op Hospital
Address
1-7-7 Nagase-cho, Higashiosaka City, Osaka, Japan
Tel
0570-04-3131
genius_intend@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
特別養護老人ホームかわちの里ながせ（大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 20 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | 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 | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054464
