UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035973 |
|---|---|
| Receipt number | 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 | 2021/02/23 13:11:46 |
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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
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
https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040969
keiko816@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
京都府立医科大学医学部附属病院
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 03 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 03 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 22 | Day |
Last modified on
| 2021 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040969
| Research Plan | |
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| 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 |
