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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026615
Receipt No. R000030568
Scientific Title The effects of aerobic and resistance exercise on intraocular pressure with type 2 diabetes
Date of disclosure of the study information 2017/03/31
Last modified on 2019/07/03

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Basic information
Public title The effects of aerobic and resistance exercise on intraocular pressure with type 2 diabetes
Acronym The effects of exercise on intraocular pressure with type 2 diabetes
Scientific Title The effects of aerobic and resistance exercise on intraocular pressure with type 2 diabetes
Scientific Title:Acronym The effects of exercise on intraocular pressure with type 2 diabetes
Region
Japan

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

Objectives
Narrative objectives1 This study aimed to investigate exercise intensity and style effects on intraocular pressure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Exercise intensity and intraocular pressure
Exercise mode and intraocular pressure
Key secondary outcomes Knee extension force
Predicted maximum oxygen uptake

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy control group
A total of 20 male students at Hiroshima University Institute of Health Sciences. Exclusion criteria comprised exercise-limiting joint disorders, intraocular pressure over 20 mmHg, and any other diseases contraindicating exercise.
Diabetes group
Hiroshima University Hospital Department of Endocrinology and Diabetic Medicine inpatients capable of undergoing exercise therapy and who had been referred to the Department of Rehabilitation for the purpose of exercise therapy intervention. Exclusion criteria were the same as for the healthy control group.
Key exclusion criteria 1. Patients who could not adapt to the exercise therapy.
2. Independent walking is impossible.
3. Significant limitations in their activities of daily of living.
4. Severe heart and/or respiratory diseases.
5. Severe liver dysfunction and/or renal failure (serum creatinine over 2.0 mg/dL).
6. Patients having acute and/or chronic orthopedic disease, and who were presently receiving medical treatment.
7. Patients having non-symmetry of bilateral lower-extremity muscular atrophy.
8. Patients having an impairment of the lower-extremities.
9. Patients having severe infectious disease.
10. Patients requiring surgical treatment.
11. Other conditions that resulted in the patients being considered to be ineligible by the researcher.

Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kimura
Organization Hiroshima University Hospital
Division name Department of Rehabilitation
Zip code 734-8551
Address 1-2-3 kasumi minami-ku Hiroshima
TEL 082-257-5566
Email luna@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Toshihiro
Middle name
Last name Kawae
Organization Tohto University
Division name Department of Physical Therapy, Makuhari Human Care
Zip code 261-0021
Address 1-3 Nakase Makuhari Mihama-ku Chiba City, Chiba, 261-8501, Japan
TEL 043-273-1111
Homepage URL http://ptdm.jp/
Email toshihiro.kawae@tohto.ac.jp

Sponsor
Institute Kansai University of Welfare Sciences
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

Other related organizations
Co-sponsor Kansai University of Welfare Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University
Address 1-2-3 kasumi minami-ku Hiroshima
Tel 082-257-5566
Email toshihiro.kawae@tohto.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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 31 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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
2018 Year 07 Month 02 Day
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ethic committee admitted the this study.

Management information
Registered date
2017 Year 03 Month 20 Day
Last modified on
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030568

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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