UMIN-CTR Clinical Trial

Basic information
Public title	Pilot study for a randomized controlled trial of preventing locomotive syndrome through exercise at local pharmacies
Acronym	Pilot study for preventing locomotive syndrome through exercise at local pharmacies
Scientific Title	Pilot study for a randomized controlled trial of preventing locomotive syndrome through exercise at local pharmacies
Scientific Title:Acronym	Pilot study for preventing locomotive syndrome through exercise at local pharmacies
Region	Japan

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

Objectives
Narrative objectives1	To conduct a pilot study for a randomized controlled trial to examine the feasibility and the efficacy of the exercises for preventing locomotive syndrome at local pharmacies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Locomotive syndrome risk test: the two-step test
Key secondary outcomes	Locomotive syndrome risk test: the stand-up test, 25-question risk assessment One-leg standing time with eyes open Leg strength evaluation SF-8 Number of times the participant comes to the pharmacy during the research period The pharmacist's advices given at the pharmacy regarding the participant's health conditions Information of the participant's health conditions obtained by the pharmacist during the research period Number of participants who could not come to the pharmacy on the scheduled date The exercise rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The exercise lesson Pharmacists check that the participants do the exercises correctly once a month at the pharmacy
Interventions/Control_2
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Person who meets all the following criteria: Age 65 or older at the time of consent Person who is unable to stand up from a height of 40 cm on one leg, either your right leg or left leg Person who gives his/her consent in writing to participate in the study
Key exclusion criteria	Person whose doctor orders not to do exercise Person with the certification of needed long-term care Person who has received a diagnosis of mental disorders Person who goes to sports facilities and receives exercise guidance on a regular basis Person whose locomotive syndrome risk is level 2 Person who does not come to the pharmacy after the observation period Person with joint range of motion limitation Person with pain, swelling, inflammation, injury, paralysis, or skin lesion of the lower limbs Person who is allergic to the materials of leg-strength evaluation tools
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Chigusa Middle name Last name Kikuchi
Organization	Nagoya City University Graduate School of Pharmaceutical Sciences
Division name	Department of Clinical Pharmacy
Zip code	467-8603
Address	3-1 Tanabe-dori, Mizuho-ku, Nagoya, Japan
TEL	+81-52-836-3460
Email	kikuchi@phar.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Chigusa Middle name Last name Kikuchi
Organization	Nagoya City University Graduate School of Pharmaceutical Sciences
Division name	Department of Clinical Pharmacy
Zip code	467-8603
Address	3-1 Tanabe-dori, Mizuho-ku, Nagoya, Japan
TEL	+81-52-836-3460
Homepage URL
Email	kikuchi@phar.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	OTC Self-Medication Promotion Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya City University Hospital Clinical Research Review board
Address	1 Kawasumi, Mizuho-ku, Nagoya 467-8603, Japan
Tel	+81-52-853-8321
Email	clinical_research@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

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 28 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	2017 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date	2017 Year 06 Month 28 Day
Last follow-up date	2018 Year 03 Month 26 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 28 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032034