UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose the Locomotion training improve physical function for elderly people with vitamin D supplementation dramatically?
Title of the study (Brief title)	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	KANA AOKI
Organization	Niigata Nishikan Medical Center Hospital
Division name	Department of Rehabilitation
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	KANA AOKI
Organization	Niigata Nishikan Medical Center Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	Oral presentation at 28th Japanese Society for Musculoskeletal Medicine
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