UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024416
Receipt No. R000028090
Scientific Title Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
Date of disclosure of the study information 2016/10/15
Last modified on 2019/04/18

* 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 Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
Acronym Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
Scientific Title Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
Scientific Title:Acronym Effect of intensive support of exercise therapy on locomotive syndrome prevention in elderly patients with diabetes.
Region
Japan

Condition
Condition Type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of a regular semipersonalized support for exercise therapy by text-messages or calls on muscle strength, muscle mass and glycemic control in elderly patients with diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Muscle strength
Key secondary outcomes Skeletal muscle mass
Mortor function
Glycemic control
Satisfaction with the exercise therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Regular support by text-messages or calls in addition to usual care during the half year.
Interventions/Control_2 To implement the usual care in outpatient setting during the half year.
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients with type 2 diabetes mellitus
Key exclusion criteria 1. Patients with bone and joint disease or cerebral vascular disease.
2. Patients whose daily activities and highly restricted.
3. Patients with acute metabolic disorders.
4. Patients with severe chronic complications of diabetes.
5. Patients who seem inappropriate for this study by investigations.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takuo
Middle name
Last name Nomura
Organization Kansai University of Welfare Sciences
Division name Department of Rehabilitation Science, Faculty of Allied Health Sciences
Zip code 582-0026
Address 11-1, Asahigaoka, 3-chome, Kashiwara, Osaka 582-0026, Japan
TEL 072-978-0088
Email tnomura@fuksi-kagk-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Kataoka
Organization Okayama Institute for Medical and Technical
Division name Department of Physiotherapy
Zip code 700-0913
Address 3-2-18, Daiku, Kitaku, Okayama-city, Okayama, 700-0913, Japan
TEL 086-233-8020
Homepage URL http://ptdm.jp/program1.html
Email h.kataoka59@gmail.com

Sponsor
Institute Kansai University of Welfare Sciences
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Hiroshima University Hospital
Sanuki Municipal Hospital
Kimitsu Chuo Hospital
Chiba central Medical Center
Shuto General Hospital
Sakaide City Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization KKR Takamatsu Hospital
Address 4-18, Tenjinmae, Takamatsu-city, Kagawa, 760-0018, Japan
Tel 087-861-3261
Email irb@kkr-ta-hp.gr.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 KKR高松病院(香川県),さぬき市民病院(香川県),君津中央病院(千葉県),千葉中央メディカルセンター(千葉県),周東総合病院(山口県),坂出市立病院(香川県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 15 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
2016 Year 09 Month 16 Day
Date of IRB
2016 Year 06 Month 17 Day
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 01 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 01 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information http://ptdm.jp/policy.html

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.