UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040658 |
|---|---|
| Receipt number | R000046409 |
| Scientific Title | Effects of high intensity interval walking training on muscle strength in dynapenic patients with diabetes. |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2024/04/08 13:30:59 |
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Basic information
Public title
Effects of high intensity interval walking training on dynapenia
Acronym
Effects of high intensity interval walking training on dynapenia
Scientific Title
Effects of high intensity interval walking training on muscle strength in dynapenic patients with diabetes.
Scientific Title:Acronym
Effects of high intensity interval walking training on muscle strength in dynapenic patients with diabetes.
Region
| Japan |
Condition
Condition
Type1 and Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effects of high intensity interval walking training on increasing muscle strength in dyanapenic patients with diabetes using a randomized controlled design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee extension strength
The differences in outcome variables, measured in the pre-, middle (3-mounths), and post-intervention (5-months) periods.
Key secondary outcomes
Secondary outcome: gait speed, VO2 peak, Health related QOL,
Other outcome: BMI, skeletal muscle mass index, grip strength, fall risk index, mini nutritional assessment, HbA1c, eGFR, physical activity, skin autofluorescence, urinary albumin, nutrition intake.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
High intensity interval walking training(combined with fast walking at 70% or more of estimated maximum oxygen intake and slow walking at 40%in 3 minutes each) for 5 months(more than 120 minute-interval per week).
Interventions/Control_2
Usual walking for 5 months (more than 120 minutes per week).
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with type 1 and type 2 diabetes, who are able to exercise at 70% intensity of peak heart rate
Key exclusion criteria
People with cardiac pacemaker
People with joint pain and movement restriction at the knee and waist.
People in another clinical study, within 2 months prior to the start of this study
People who are unable to continue the intervention
People treated with severe peripheral neuropathy, retinopathy, chronic kidney disease, or cardiovascular disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Munehide |
| Middle name | |
| Last name | Matsuhisa |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8011
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7587
matuhisa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Mori |
Organization
Tokushima University
Division name
Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7587
Homepage URL
mori.hiroyasu@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
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
Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address
2-50-1 Kuramoto, Tokushima
Tel
0886339347
awachiken@tokushima-u.ac.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
| 2020 | Year | 09 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046409
| 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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| Registered date | File name |
