UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054698 |
|---|---|
| Receipt number | R000062508 |
| Scientific Title | Examination of the effectiveness of health support interventions aimed at preventing disorders of the locomotor system in pharmacies |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2025/12/18 16:44:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effectiveness of health support interventions aimed at preventing disorders of the locomotor system in pharmacies
Acronym
Health support at pharmacies
Scientific Title
Examination of the effectiveness of health support interventions aimed at preventing disorders of the locomotor system in pharmacies
Scientific Title:Acronym
Health support at pharmacies
Region
| Japan |
Condition
Condition
disorders of the locomotor system
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the number of people affected by locomotive syndrome, including those in the pre-morbid group, is about 47 million, and frailty affects about 10% of the elderly (65 years and older). Locomotive syndrome and physical frailty, which are caused by disorders of the locomotor system, are the most important factors preventing the extension of healthy life expectancy, and their prevention is a pressing issue in Japan. The importance of daily health management and self-medication has been touted for the prevention of locomotor disorders, and since the Health Support Pharmacy System came into effect in 2016, the role of pharmacists in promoting self-medication among community residents has become increasingly important. In previous studies, there is a high need for pharmacies to support the health of community residents, and many studies have reported the effectiveness of pharmacies in doing so. In recent years, pharmacists, dietitians, and physical therapists have collaborated to provide health support and exercise guidance for the prevention of musculoskeletal disorders, and the effectiveness of these efforts has been reported. However, there have been few studies that have examined the effects of preventing musculoskeletal disorders by having patients and visitors learn about their current physical condition, and then examining their own awareness, behavior, and physical changes afterwards. Therefore, the purpose of this study was to verify the effectiveness of health support centering on the prevention of musculoskeletal disorders through collaboration between sports health science specialists and pharmacists, and to measure the awareness, behavior, and physical changes before and after the implementation of the program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Weight, body fat percentage, muscle mass, bone density, leg strength, locomotive syndrome susceptibility measurement [stand-up box (4 different height platforms are set up, one on each leg) 2 step mat (walk 2 steps as large as possible, twice)], grip strength
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 45 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be male and female patients aged 45 years or older who visit the pharmacy where the research partner works, excluding patients for whom exercise is contraindicated and patients suffering from hypertension, cerebrovascular disease, or cardiac disease, and who have given their consent. Participants will be recruited by talking to patients visiting the pharmacy and by posting flyers. In addition, in order to minimize participant selection bias, all patients who visit the pharmacy will be approached at the store where the measurement session is to be held, after clarifying the conditions for participants.
Key exclusion criteria
Patients for whom exercise is contraindicated, those suffering from hypertension, cerebrovascular disease, or cardiac disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Onuma |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Health and Sports Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba, Japan
TEL
047-465-5827
onuma.naoko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Onuma |
Organization
School of Pharmacy, Nihon University
Division name
Laboratory of Health and Sports Science
Zip code
274-8555
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba, Japan
TEL
047-465-5827
Homepage URL
onuma.naoko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Human Subjects Research Ethics Review Committe
Address
7-7-1 Narashinodai, Funabashi-shi, Chiba, Japan
Tel
047-465-5919
pha.res-staff@nihon-u.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
| 2024 | Year | 06 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Participants] Men and women aged 45 or older who meet the selection criteria and who visit the pharmacy once every two to three months to purchase OTC drugs or patients who use the pharmacy as their family pharmacy. Participants will be selected at any time during the 2 years of the 3-year research period in conjunction with the measurement sessions (selection period: from after approval to October 31, 2025).
[Location]Several pharmacies in Chiba Prefecture that are in a cooperative relationship with the research partner.
[Procedure]
(1) When patients who meet the selection criteria come to the pharmacies, the study will be explained to them using an explanatory document. Patients who have indicated their willingness to participate in the study will be asked to come back to the pharmacy at a later date.
(2) After the participant's visit, the study will be explained again using the explanatory document, and consent will be obtained on the consent form upon understanding and agreeing to the content of the explanation.
(3) We will conduct a survey on the participants' awareness of their own health management and behavior, as well as an existing questionnaire to determine the degree of locomotive syndrome.
(4) After measuring body temperature, pulse, blood pressure, and interviewing the participants, body composition, ultrasonic bone densitometry, gait posture measurement, leg strength measurement, locomotive syndrome incidence measurement, and grip strength measurement (Azwan) will be conducted (all non-invasive) in order to understand their own health and current physical condition.
(5) When the next prescription is received or when the patient visits the clinic (2 to 3 months later), the same surveys and measurements as described in (3) and (4) will be conducted.
(6) Analyze the measurement results to measure health awareness, behavior, and physical changes before and after the implementation of health support, and verify the effects.
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062508
