UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035867
Receipt number 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 2023/09/15 11:14:05

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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 Chigusa
Middle name
Last name Kikuchi

Organization

Showa Pharmaceutical University

Division name

Laboratory of Community Medicine

Zip code

194-8543

Address

3-3165 Higashitamagawagakuen Machida Tokyo

TEL

+81-42-721-1535

Email

c-kikuchi@ac.shoyaku.ac.jp


Public contact

Name of contact person

1st name Chigusa
Middle name
Last name Kikuchi

Organization

Showa Pharmaceutical University

Division name

Laboratory of Community Medicine

Zip code

194-8543

Address

3-3165 Higashitamagawagakuen, Machida, Tokyo

TEL

+81-42-721-8543

Homepage URL


Email

c-kikuchi@ac.shoyaku.ac.jp


Sponsor or person

Institute

Showa Pharmaceutical University

Institute

Department

Personal name



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

Nagoya City University Certified Review Board

Address

1 kawasumi, Mizuho-ku, Nagoya

Tel

+81-52-853-8348

Email

rinshou-kenkyu@med.nagoya-cu.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

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

54

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

Completed

Date of protocol fixation

2018 Year 12 Month 18 Day

Date of IRB

2018 Year 12 Month 18 Day

Anticipated trial start date

2019 Year 03 Month 24 Day

Last follow-up date

2023 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 02 Month 13 Day

Last modified on

2023 Year 09 Month 15 Day



Link to view the page

Value
https://center6.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