UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044093 |
|---|---|
| Receipt number | 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 | 2023/05/03 09:26:58 |
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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
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
minaminagasaki2007@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
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
| 2023 | Year | 05 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050353
