UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034742
Receipt No. R000039284
Official scientific title of the study Improvements in Physical Functions and healthcare economic evaluation with foot care and exercise in elderly people
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/01

* 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
Official scientific title of the study Improvements in Physical Functions and healthcare economic evaluation with foot care and exercise in elderly people
Title of the study (Brief title) Foot care for Improvements in Physical Functions
Region
Japan

Condition
Condition Elderly
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim to investigate the effect of foot care and exercise on improvement in physical function, activity and medical cost in elderly people
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement in lower limb muscle strength for baseline and 5 months
Key secondary outcomes Foot pressure distribution, questionnaires and medical cost

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Perform foot care once a month
Interventions/Control_2 Perform exercise once a month
Interventions/Control_3 control
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 Possibility of walking independently
Communication is possible through conversation
Key exclusion criteria Subjects for whom we could not obtain a physician's approval

Target sample size 400

Research contact person
Name of lead principal investigator Kazuhiko Yamashita
Organization Takase Clinic
Division name Community Health Laboratory
Address 1-16-6 Shimomaruko Ota-ku Tokyo
TEL 03-5732-2525
Email k-yamashita@takase-cl.org

Public contact
Name of contact person Kazuhiko Yamashita
Organization Takase Clinic
Division name Community Health Laboratory
Address 1-16-6 Shimomaruko Ota-ku Tokyo
TEL 03-5732-2525
Homepage URL
Email k-yamashita@takase-cl.org

Sponsor
Institute Takase Clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shiki City Office in Saitama Prefecture
Name of secondary funder(s) Medical Foot care JF Association

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 埼玉県志木市,秋田県潟上市,秋田県三種町

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 01 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039284

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.