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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035867
Receipt No. R000040860
Scientific Title Non-randomized controlled trial of preventing locomotive syndrome through training at pharmacies
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/13

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Basic information
Public title Non-randomized controlled trial of preventing locomotive syndrome through training at pharmacies
Acronym Comparative study for preventing locomotive syndrome at pharmacies
Scientific Title Non-randomized controlled trial of preventing locomotive syndrome through training at pharmacies
Scientific Title:Acronym Comparative study for preventing locomotive syndrome at pharmacies
Region
Japan

Condition
Condition Locomotive syndrome
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of training at pharmacies for 25-question risk assessment of locomotive syndrome risk test and lower limb muscle strength.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Weight Bearing Index in 6 months
Key secondary outcomes Locomotive syndrome risk test
Lower limb blood flow
SF-8
One-leg standing time with eyes open
Number of times visiting pharmacy
Contents of advice
Information of health condition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
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 Interventions
Instruction for locomotion training for 6 months
Interventions/Control_2 Control
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
85 years-old >
Gender Male and Female
Key inclusion criteria A member of kinds of senior citizens' clubs around the pharmacy who meets all the following criteria:
1) Age 65 or older and under age 85 at the time of consent
2) Person gives consent in writing to participate in the study
3) Locomotive syndrome risk is level 1
Key exclusion criteria 1) Confirm that prohibition of exercise from subjects or doctors
2) Certification of long-term care need
3) Diagnosis of mental disorders
4) Receives exercise guidance at sports facilities
5) Unfinished all tests
6) Motion limitation of joint range
7) Pain, swelling, inflammation, injury, paralysis, or skin lesion of legs
8) Allergic to testing devices (locomoscan, assist frame, prove of rheometer)
9) Principal investigator may consider unsuitable for participants
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chigusa Kikuchi
Organization Graduate School of Pharmaceutical Sciences, Nagoya City university
Division name Department of Clinical Pharmacy
Zip code
Address 3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL +81-52-836-3460
Email kikuchi@phar.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Kikuchi
Organization Graduate School of Pharmaceutical Sciences, Nagoya City university
Division name Graduate School of Pharmaceutical Sciences, Nagoya City university
Zip code
Address 3-1 Tanabe-dori, Mizuho-ku, Nagoya
TEL +81-52-836-3460
Homepage URL
Email kikuchi@phar.nagoya-cu.ac.jp

Sponsor
Institute Graduate School of Pharmaceutical Sciences, Nagoya City university
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 浅井薬局橘店(愛知県)/Asai pharmacy Tachibana (Aichi)
浅井薬局太閤店(愛知県)/Asai pharmacy Taikoh (Aichi)
キョーワ薬局大江店(愛知県) /Kyowa pharmacy Ooe (Aichi)
キョーワ薬局諸輪店(愛知県) /Kyowa pharmacy Morowa (Aichi)
松栄堂薬局(愛知県) /Shoueidoh pharmacy (Aichi)
はるか薬局栄生(愛知県) /Haruka pharmacy Sakoh (Aichi)
フジ調剤薬局七宝店(愛知県)/Fuji chohzai pharmacy Shippoh (Aichi)
やまざき薬局浜松上島店(静岡県)/Yamazaki pharmacy Hamamatsu Kmijima (Shizuoka)
ゆたか調剤薬局(愛知県)/Yutaka chohzai pharmacy (Aichi)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 13 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 Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040860

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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