UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026615 |
|---|---|
| Receipt number | 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 | 2020/03/22 14:04:32 |
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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
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/
toshihiro.kawae@tohto.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
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
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
| 2025 | 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
| 2020 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030568
