UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037945 |
|---|---|
| Receipt number | R000043188 |
| Scientific Title | Effects of a sit-to-stand exercise on type 2 diabetes patients |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2024/04/11 10:05:34 |
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Basic information
Public title
Effects of a sit-to-stand exercise on type 2 diabetes patients
Acronym
Effects of a sit-to-stand exercise on type 2 diabetes patients
Scientific Title
Effects of a sit-to-stand exercise on type 2 diabetes patients
Scientific Title:Acronym
Effects of a sit-to-stand exercise on type 2 diabetes patients
Region
| Japan |
Condition
Condition
patients with type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the repeated sit-to-stand exercise for patients with type 2 siabetes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) physical capacity
Key secondary outcomes
2) leg muscular strength
3) walking speed
4) functional reaching distance
5) HbA1c
6) exercise self efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
usual medical treatment guidance and aerobic exercise using a repeated sit-to-stand exercise (10 minutes per 1 set, 2set per day, at least 3 days or more, 8 weeks)
Interventions/Control_2
Only medical treatment guidance
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with type 2 diabetes
(Participants who met the American Diabetes Association diagnosis criteria)
Key exclusion criteria
1) a fasting plasma glucose level over 250 mg/dL
2) proliferative retinopathy,
3) severe peripheral neuropathy,
4) nephropathy (overt nephropathy, stage 3; renal failure, stage 4),
5) autonomic neuropathy, or orthopedic diseases with a physical impairment that could interfere with exercise.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakamura |
Organization
Matsumoto city hospital
Division name
Rehabilitation
Zip code
3901401
Address
4417-180, Hata, Matsumoto
TEL
0263923027
keipons55@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Nakamura |
Organization
Matsumoto City Hospital
Division name
Rehabilitation
Zip code
3901401
Address
4417-180, Hata, Matsumoto
TEL
0263923027
Homepage URL
keipons55@yahoo.co.jp
Sponsor or person
Institute
Matsumoto City Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu Public Utility Foundation for promotion of medical science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsumoto City Hospital
Address
4417-180, Hata, Matsumoto
Tel
0263923027
keipons55@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
| 2019 | Year | 09 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043188
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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