UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028229 |
|---|---|
| Receipt number | R000032310 |
| Scientific Title | Dose the Locomotion training improve physical function for elderly people with vitamin D supplementation dramatically? |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2017/08/25 13:26:33 |
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Basic information
Public title
Dose the Locomotion training improve physical function for elderly people with vitamin D supplementation dramatically?
Acronym
Exercise and vitamin D for elderly
Scientific Title
Dose the Locomotion training improve physical function for elderly people with vitamin D supplementation dramatically?
Scientific Title:Acronym
Exercise and vitamin D for elderly
Region
| Japan |
Condition
Condition
Community-dwelling elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of exercise and vitamin D supplementation on physical function in community-dwelling elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes on lower limb muscle strength and lower limb muscle mass between baseline and at 24 weeks
Key secondary outcomes
Changes on several physical function scales (the two-step test, the single-leg stance test the five times sit to stand test and the functional reach test), the 25-question Geriatric Locomotive Function Scale and serum 25-hydroxyvitamin D levels between baseline and at 24weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Single-leg standing with eyes open, three sets a day of 1 min of standing on each leg per set, 24wks
Interventions/Control_2
Squatting, three sets a day of five or six squats per set, 24wks
Interventions/Control_3
25 mcg of vitamin D supplementation per day, 24wks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult aged 60 or over who were not taking medications for osteoporosis.
Key exclusion criteria
1) detected taking osteoporosis medications that included an active vitamin D3 agent, calcium, bisphosphonates, selective estrogen receptor modulators (SERMs), teriparatide, or denosumab by the interview,
2) severely impaired to perform exercise
3) having condition not to take vitamin D
4) after pacemaker implantation,
5) impossible to participate reserved study visit pre and post intervention. Eligibility was assessed for the people who were propose to participate through
Target sample size
192
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | KANA AOKI |
Organization
Niigata Nishikan Medical Center Hospital
Division name
Department of Rehabilitation
Zip code
Address
4368, Maki-Kou, Nishikan-Ku, Niigata, Niigata, Japan
TEL
0256-72-3111
horiikan@mail.interq.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KANA AOKI |
Organization
Niigata Nishikan Medical Center Hospital
Division name
Department of Rehabilitation
Zip code
Address
4368, Maki-Kou, Nishikan-Ku, Niigata, Niigata, Japan
TEL
0256-72-3111
Homepage URL
horiikan@mail.interq.or.jp
Sponsor or person
Institute
Department of Regenerative and Transplant Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Musculoskeletal Medicine
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
Address
Tel
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
新潟大学大学院医歯学総合研究科
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Oral presentation at 28th Japanese Society for Musculoskeletal Medicine
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
| 2014 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 24 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 07 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 07 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032310
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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