UMIN-CTR Clinical Trial

Basic information
Public title	Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Acronym	Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Scientific Title	Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Scientific Title:Acronym	Effects of stair climbing-descending exercise for a short time on glycemic control in people with type 2 diabetes
Region	Japan

Condition
Condition	Type 2 diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of regular stair climbing-descending exercise on glycemic control in people with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Term for evaluation At baseline, at 12 weeks, and at 24 weeks Evaluation items Glycemic control (HbA1c)
Key secondary outcomes	Term for evaluation At baseline, at 12 weeks, and at 24 weeks Evaluation items 1. Fasting plasma glucose, homeostasis model assessment of insulin resistance (HOMA-IR) 2. Muscle strength 3. Skeletal muscle mass, body Fat Mass

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Regular stair climbing-descending exercise in addition to oral guidance using exercise materials for 24 weeks.
Interventions/Control_2	Oral guidance using exercise materials for 24 weeks.
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Outpatients with type 2 diabetes
Key exclusion criteria	1. Patients who have been diagnosed with diabetes for less than a year 2. Patients whose daily physical activities restricted by cardiovascular or motor dysfunction 3. Patients with severe chronic complications of diabetes. 4. Patients with cognitive decline 5. Patients who do not have appropriate stairs using study in their living environments
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Hiroto Middle name Last name Honda
Organization	Aino University
Division name	Department of Physical Therapy, Faculty of Health Sciences
Zip code	567-0012
Address	4-5-4 Higashioda, Ibaraki, Osaka
TEL	072-627-1711
Email	h-honda@pt-u.aino.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Honda
Organization	Aino University
Division name	Department of Physical Therapy, Faculty of Health Sciences
Zip code	567-0012
Address	4-5-4 Higashioda, Ibaraki, Osaka
TEL	072-627-1711
Homepage URL
Email	h-honda@pt-u.aino.ac.jp

Sponsor
Institute	Aino University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Aino University
Address	4-5-4 Higashioda, Ibaraki, Osaka
Tel	072-627-1711
Email	h-honda@pt-u.aino.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	公立豊岡病院日高医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 11 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 07 Month 07 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2021 Year 12 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 01 Month 11 Day
Last modified on	2021 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049058

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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