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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044093
Receipt No. R000050353
Scientific Title Examination of muscle hypertrophy effect by conducting voluntary training for type 2 diabetic patients
Date of disclosure of the study information 2021/05/10
Last modified on 2021/05/01

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Basic information
Public title Examination of muscle hypertrophy effect by conducting voluntary training for type 2 diabetic patients
Acronym Examination of muscle hypertrophy effect by conducting voluntary training for type 2 diabetic patients
Scientific Title Examination of muscle hypertrophy effect by conducting voluntary training for type 2 diabetic patients
Scientific Title:Acronym Examination of muscle hypertrophy effect by conducting voluntary training for type 2 diabetic patients
Region
Japan

Condition
Condition type 2 diabetic patients
Classification by specialty
Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to conduct a randomized controlled trial in order to verify the effect of muscle hypertrophy by conducting this voluntary training that can be performed at home in patients with high-risk type 2 diabetes who fall.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body composition
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Voluntary training at home (resistance exercise, balance exercise)
Interventions/Control_2 Normal activities of daily living
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1, Patients who can walk independently and are independent of activities of daily living
2, Patients whose physical ability was evaluated by a physiotherapist during the hospitalization period
3, Fall high-risk patients extracted by fall prediction model (grip strength less than 25 kg or fasting C-peptide 2.0 or more)
Key exclusion criteria Patients with any of the following diabetic complications
A, Proliferative diabetic retinopathy (excluding patients who are stable with photocoagulation therapy)
B, NYHA (New York Heart Association) II and above
2, Patients undergoing treatment such as chemotherapy / radiation therapy for malignant tumors (excluding history)
3, Patients taking corticosteroids
4, Patients with Cushing's syndrome or acromegaly who have not been treated or are currently being treated
5, Patient after gastrectomy
6, Patients with gait disorders (non-walking independence) as movement disorders in the hip and knee joints
7, Patients with paralysis (including paresis) due to central nervous system disease
8, Patients with neuropathy (cerebral infarction, spinal canal stenosis, etc.) due to causes other than diabetes
9, Patients with cognitive impairment (lack of communication ability) who have difficulty understanding instructions
Target sample size 30

Research contact person
Name of lead principal investigator
1st name yasuhiro
Middle name
Last name suzuki
Organization University of Tsukuba Hospital
Division name Department of Rehabilitation Medicine
Zip code 305-0044
Address 2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576
TEL +819062872557
Email minaminagasaki2007@yahoo.co.jp

Public contact
Name of contact person
1st name yasuhiro
Middle name
Last name suzuki
Organization University of Tsukuba Hospital
Division name Department of Rehabilitation Medicine
Zip code 305-0044
Address 2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576
TEL +819062872557
Homepage URL
Email minaminagasaki2007@yahoo.co.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization University of Tsukuba Hospital
Address 2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576
Tel +819062872557
Email minaminagasaki2007@yahoo.co.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
2021 Year 05 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 05 Month 10 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 01 Day
Last modified on
2021 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050353

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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