UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039560 |
|---|---|
| Receipt number | R000045114 |
| Scientific Title | Improving physical function through locomotion training a prospective community-based intervention survey |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2022/08/25 14:47:27 |
* 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
Physical function through locomotion training a prospective community-based intervention survey
Acronym
Physical function through locomotion training a prospective community-based intervention survey
Scientific Title
Improving physical function through locomotion training a prospective community-based intervention survey
Scientific Title:Acronym
Improving physical function through locomotion training a prospective community-based intervention survey
Region
| Japan |
Condition
Condition
locomotive syndrome
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the changes in locomotive functions and health-related quality of life caused by exercises for preventing locomotive syndrome interventions for the elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Research subject background: age, gender, medical history, height, weight (health consultation by public health nurses)
Health-related QOL questionnaire (EuroQOL, Locomo 25)
Daily living pain and mental questionnaires (Oswestry Disability Index, Hospital anxiety and depression scales)
Locomo Scan
Walking speed (10m walking)
Key secondary outcomes
training days
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The 110 participants who underwent the gymnastics intervention were divided into three groups according to their locomotor activity according to GLFS-25.
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
| 63 | years-old | <= |
Age-upper limit
| 94 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who responded to a questionnaire on health-related QOL
2) Residents aged 60 and over who wish to exercise and obtain written consent
Key exclusion criteria
1) Those who did not respond to the questionnaire on health-related quality of life
2) Residents who do not want to exercise
3) The person in charge of the research or the research coordinator deemed inappropriate to participate in the research
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yamato |
Organization
Department of Orthopedic Surgery, Hamamatsu University School of Medicine
Division name
Division of Geriatric Musculoskeletal Health, Hamamatsu University School of Medicine
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2647
yamato@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Yamato |
Organization
Hamamatsu University School of Medicine
Division name
Department of Orthopedic Surgery, Division of Geriatric Musculoskeletal Health
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2647
Homepage URL
yamato@hama-med.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Orthopedic Surgery Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toei Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-2680
rinri@hama-med.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
| 2020 | Year | 02 | Month | 21 | 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
110
Results
In the beginning, 117 people were instructed to exercise at a local meeting place and 110 people completed a questionnaire. Since then, the training has been continued every three months. The results of the survey showed that LocoTraining improved locomotive function in subjects with the locomotive syndrome, especially in subjects with locomotive-2 and locomotive-3.
Results date posted
| 2021 | Year | 02 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The need for reconstruction in the paper.
Date of the first journal publication of results
Baseline Characteristics
65 of 110 elderly people
Participant flow
Exercises every three months for one year.
Adverse events
The start of the COVID-19 epidemic made it temporarily difficult to assemble.
Outcome measures
GLFS-25
EQ5D
ODI
Walking speed
Lower limb extensor strength (using Alcare's LocomoScan)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results will be published in an online poster presentation at the Japanese Orthopaedic Association in May 2021.
A paper is once rejected, but being reconstructing with the effects of COVID-19.
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045114
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
