UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039560
Receipt No. 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 2021/08/23

* 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
Email 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
Email yamato@hama-med.ac.jp

Sponsor
Institute Department of Orthopaedic Surgery, Hamamatsu University School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.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


Contact us.