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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000038802
Receipt No. R000044237
Scientific Title Effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Date of disclosure of the study information 2019/12/10
Last modified on 2020/06/05

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Basic information
Public title Effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Acronym Effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Scientific Title Effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Scientific Title:Acronym Effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Region
Japan

Condition
Condition Elderly diabetic patients with sarcopenia
Classification by specialty
Medicine in general Endocrinology and Metabolism Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effects of multifaceted intervention program on muscle strength and physical performance in elderly diabetic patients with sarcopenia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes muscle strength and physical performance
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Out patients who receive therapy at our hospital
HbA1c<11%
Patients diagnosed according to the AWGS2019 criteria

Patients who are capable of making a decision by themselves, and provide written cosent.
Key exclusion criteria Had ketosis or coma within 6 month
Poor-controlled diabetes (HbA1c>11.0 % )
History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months
Patients with hepatic failure and renal failure
Malignancies or other diseases with poor prognosis
Target sample size 15

Research contact person
Name of lead principal investigator
1st name kazuya
Middle name
Last name murata
Organization Ise Red Cross Hospital
Division name Department of diabetes and metabolism
Zip code 516-0008
Address 471-2, Funae, 1-chome, Ise-shi, Mie
TEL 0596-28-2171
Email bboy98762006@yahoo.co.jp

Public contact
Name of contact person
1st name satoshi
Middle name
Last name ida
Organization Ise Red Cross Hospital
Division name Department of diabetes and metabolism
Zip code 516-8512
Address 1-471-2, Funae, 1-chome
TEL 0596282171
Homepage URL
Email bboy98762006@yahoo.co.jp

Sponsor
Institute Ise Red Cross Hospital
Institute
Department

Funding Source
Organization Ise Red Cross Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the ethics committee of the Ise Red Cross Hospital
Address 1-471-2, Funae, 1-chome
Tel 0596282171
Email jimubu@ise.jrc.or.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
2019 Year 12 Month 10 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
2019 Year 12 Month 05 Day
Date of IRB
2019 Year 12 Month 01 Day
Anticipated trial start date
2019 Year 12 Month 10 Day
Last follow-up date
2020 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 12 Month 05 Day
Last modified on
2020 Year 06 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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