UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036258 |
|---|---|
| Receipt number | R000041297 |
| Scientific Title | The effects of low-load resistance training with slow movement and tonic force generation on muscle size and physical function in low fitness adults |
| Date of disclosure of the study information | 2019/03/21 |
| Last modified on | 2021/05/06 12:45:28 |
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Basic information
Public title
The effects of low-load resistance training with slow movement and tonic force generation on muscle size and physical function in low fitness adults
Acronym
The effects of slow resistance training on muscle size and physical function in low physical fitness adults
Scientific Title
The effects of low-load resistance training with slow movement and tonic force generation on muscle size and physical function in low fitness adults
Scientific Title:Acronym
The effects of slow resistance training on muscle size and physical function in low physical fitness adults
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of low-load resistance training with slow movement and tonic force generation on muscle size and physical function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skeletal muscle mass, body composition, muscle strength, muscular power, balance, gait ability, locomotive syndrome resk test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Low-load resistance training with slow movement and tonic force generation
12 weeks
Twice a week
Interventions/Control_2
Normal rehabilitation
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Orthopedic patient who meets all the following criteria:
1) Age 50 or older at the time of consent
2) Subject gives consent in writing to participate in the study
3) Locomotive syndrome risk is level 1 or 2
Key exclusion criteria
1) Subject who is evaluated as inadequate subject by principal or co-principal investigators, or medical doctor because of difficulty of exercise conducting.
2) Subject with problem in cognitive function
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Watanabe |
Organization
Doshisha University
Division name
Facalty of Health and Sports Science
Zip code
610-0394
Address
1-3 Miyakodani Tatara, Kyotanabe City, Kyoto
TEL
0774-65-6720
yuwatana@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Yuya |
| Middle name | |
| Last name | Watanabe |
Organization
Doshisha University
Division name
Facalty of Health and Sports Science
Zip code
610-0394
Address
1-3 Miyakodani Tatara, Kyotanabe City, Kyoto
TEL
0774-65-6720
Homepage URL
yuwatana@mail.doshisha.ac.jp
Sponsor or person
Institute
Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Musculoskeletal Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Doshisha University
Address
Karasuma-higashi-iru, Imadegawa-dori, Kamigyo-ku, Kyoto
Tel
075-251-3158
ji-rinri@mail.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
| 2019 | Year | 03 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041297
