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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035973
Receipt No. R000040969
Scientific Title A study on the usefulness of exercise and home blood pressure in diabetic patients
Date of disclosure of the study information 2019/03/06
Last modified on 2019/05/30

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Basic information
Public title A study on the usefulness of exercise and home blood pressure in diabetic patients
Acronym Effect of exercise on home blood pressure in diabetic patients
Scientific Title A study on the usefulness of exercise and home blood pressure in diabetic patients
Scientific Title:Acronym Effect of exercise on home blood pressure in diabetic patients
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will examine the superiority of randomized comparison between exercise therapy lead group and exercise therapy lag group for diabetic patients who undergo outpatient visit treatment, for the utility of exercise therapy for domestic blood pressure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main endpoint is the average value of nocturnal blood pressure from 24 to 28 days after exercise therapy compared with when exercise therapy is not performed.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 During exercise therapy, we instruct the patient to conduct exercise therapy more than 3 days a week, 30 minutes walk twice a day or 60 minutes walk once a day for 2 weeks as guidance of exercise therapy.
Interventions/Control_2 While exercise therapy is not performed, we instruct the patient not to do any exercise therapy during the research period.
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 Selection criteria are that diagnosis of diabetes is obtained based on diagnostic criteria of Japanese Diabetes Society, that it is a case of 20 years old or younger than 90 years old, and that the patient consent was obtained from the patient himself before registration in the study.
Key exclusion criteria Patients whose urine ketone bodies are more moderate or more positive, have kidney dysfunction, or undergoing hemodialysis treatment.
Patients with advanced diabetic autonomic neuropathy, or fresh bleeding due to proliferative retinopathy.
Patients with serious liver disease or endocrine disorder.
Patients with heart lung disease, cerebrovascular disease and orthopedic disease that are difficult to exercise.
Patients who are considered inappropriate for participation by responsible researcher or attending physician for other safety reasons.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name Michiaki
Middle name
Last name Fukui
Organization Kyoto Prefectural University of Medicine
Division name Department of Endocrinology and Metabolism
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL +81-75-251-5505
Email michiaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Iwai
Organization Kyoto Prefectural University of Medicine
Division name Department of Endocrinology and Metabolism
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5506
Homepage URL
Email keiko816@koto.kpu-m.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Administration grant (classroom fee)
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 Keiko Iwai
Address 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
Tel 075-251-5506
Email keiko816@koto.kpu-m.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
2019 Year 03 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 22 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040969

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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