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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028229
Receipt No. 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

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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
Email 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
Email horiikan@mail.interq.or.jp

Sponsor
Institute Department of Regenerative and Transplant Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032310

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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