UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034465 |
|---|---|
| Receipt number | R000039212 |
| Scientific Title | The investigation of the influence of physical exercise based on exercise intensity on the indices of skeletal muscle in the older diabetic patients with frailty |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2023/04/30 16:43:54 |
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Basic information
Public title
The investigation of the influence of physical exercise based on exercise intensity on the indices of skeletal muscle in the older diabetic patients with frailty
Acronym
The influence of physical exercise based on exercise intensity on physical frailty
Scientific Title
The investigation of the influence of physical exercise based on exercise intensity on the indices of skeletal muscle in the older diabetic patients with frailty
Scientific Title:Acronym
The influence of physical exercise based on exercise intensity on physical frailty
Region
| Japan |
Condition
Condition
older patients with type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To consider the timing and intervention effect(blood sugar control,physical function) of skeletal muscle characteristics (quantitative/qualitative) using echoes in exercise intensity intervention in the elderly diabetes patients aged 65 or older who showed physical frail, and its relationship with biochemical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in skeletal muscle characteristics (quantitative/qualitative) by intervention according to intensity.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary intervention:We explained the patients about vegetarian meals, less than 60% of carbohydrates,unsaturated fatty acids, protein intake and so on.
Interventions/Control_2
Dietary & Exercise intervention:We explained the patients about vegetarian meals, less than 60% of carbohydrates,unsaturated fatty acids, protein intake.
Exercise:Walking ( one time fifteen minutes, three times per a day) and resistance training for 20minutes about 45minutes after every meal.
Interventions/Control_3
Dietary & Exercise intervention:We explained the patients about vegetarian meals, less than 60% of carbohydrates,unsaturated fatty acids, protein intake.
Exercise:Walking ( one time fifteen minutes, three times per a day) about 45minutes after every meal.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Cases of physical frail(muscle weakness or walking speed decrease, or both).
2) Cases in which written consent to participation in this study is obtained.
Key exclusion criteria
1) the subjects with type 1 diabetes
2) the subjects with already trying appropriate dietary and exercise therapy after meals (including exercise habits)
3) the subjects with uncontrolled hypertension( SBP >= 160mmHg )
4) the subjects with effort angina, chronic heart failure and tachyarrhythmia
5) the subjects with chronic respiratory failure
6) the subjects with not able to walk by themselves
7) the subjects with cognitive impairment
8) the subjects participating other clinical investigations
9) the subjects with cases judged by attending doctors to be unsuitable for this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Akasaka |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
akasaka@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Akasaka |
Organization
Osaka University Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
Homepage URL
http://www.med.osaka-u.ac.jp/pub/geriat/www/jmeder.html
akasaka@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Geriatric and General Medicine, Osaka University Graduate School of Medicine
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2,Yamada-oka,Suita,Osaka, Osaka
Tel
06-6210-8289
handai-nintei@hp-crc.med.osaka-u.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
| 2018 | Year | 12 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2018 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039212
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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