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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040658
Receipt No. 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 2020/08/24

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Basic information
Public title Effects of high intensity interval walking training and dynapenia
Acronym Effects of high intensity interval walking training and 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 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-, in-between (6 weeks), post-intervention (24 weeks) periods, and follow-up (6, 12 weeks) periods.
Key secondary outcomes skeletal muscle mass index, visceral fat area, grip strength, leg dorsiflexion muscle strength, gait speed, VO2 peak, HR peak, Health related QOL, fall risk index, mini nutritional assessment, HbA1c, eGFR, urinary urea nitrogen excretion, physical activity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 High intensity interval walking training(between fast walking at 70% or more of estimated maximum oxygen intake and slow walking at 40% or less for 3 minutes each) for 12weeks (more than 120 minutes per week).
Interventions/Control_2 Usual walking for 12weeks (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
75 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
Joint and motor dysfunction
Participating patients in another clinical study, within 2 months prior to the start of this study
Patients who are unable to continue the intervention
Severe peripheral neuropathy, retinopathy, chronic kidney disease, or cardiovascular disease.
Target sample size 60

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
Email 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
Email mori.hiroyasu@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization Tokushima University
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 Clinical Trial Center for Developmental therapeutics, Tokushima University Hospital
Address 2-50-1 Kuramoto, Tokushima
Tel 0886339347
Email 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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2021 Year 09 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
2020 Year 06 Month 05 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046409

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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