UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027963 |
|---|---|
| Receipt number | R000032034 |
| Scientific Title | Pilot study for a randomized controlled trial of preventing locomotive syndrome through exercise at local pharmacies |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2021/01/04 14:45:24 |
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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
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
kikuchi@phar.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032034
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
