UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045318 |
|---|---|
| Receipt number | R000051753 |
| Scientific Title | Examination of the effects of exercise therapy on elderly diabetic patients focusing on basic activities of daily living |
| Date of disclosure of the study information | 2021/09/06 |
| Last modified on | 2023/09/01 09:46:03 |
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Basic information
Public title
Effects of exercise therapy on elderly diabetic patients focusing on basic activities of daily living
Acronym
Effects of exercise therapy on elderly diabetic patients Focusing on basic activities of daily living
Scientific Title
Examination of the effects of exercise therapy on elderly diabetic patients focusing on basic activities of daily living
Scientific Title:Acronym
DM-BADL study
Region
| Japan |
Condition
Condition
Type2 Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reveal the effect of exercise therapy on basic ADL movement ability
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic ADL ability 3 months after baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise therapy instruction at least once a week - 3 months
Interventions/Control_2
Normal medical care - Exercise therapy instruction at least once a months - 3 months
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Ages from 65 to 89 at the time of consent acquisition
2 Those who feel difficulty in basic ADL operation
3 After receiving an explanation when participating in this study, the patient's free will to obtain written consent
Key exclusion criteria
1 Neuromuscular diseases
2 Dementia
3 Severe motor paralysis
4 Acute metabolic disorders
5 Severe chronic diabetic complications
6 judged by the attending physician or principal investigator to be inappropriate as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Aizawa |
Organization
Misaki Medical clinic , department of internal medicine
Division name
Exercise counseling room
Zip code
274-0805
Address
6-44-9 Futawahigashi Funabashi City Chiba Prefecture
TEL
047-440-5151
f.aizawa130@gmail.com
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Aizawa |
Organization
Misaki Medical clinic , department of internal medicine
Division name
Exercise counseling room
Zip code
274-0805
Address
6-44-9 Futawahigashi Funabashi City Chiba Prefecture
TEL
047-440-5151
Homepage URL
f.aizawa130@gmail.com
Sponsor or person
Institute
Misaki Medical clinic , department of internal medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Diabetes Education and Care
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Physical Therapy, Faculty of Makuhari Human Care, Tohato University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Misaki Medical clinic , department of internal medicine
Address
6-44-9 Futawahigashi Funabashi City Chiba Prefecture
Tel
047-440-2222
misakin@bh.wakwak.com
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
三咲内科クリニック（千葉県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 06 | Day |
Related information
URL releasing protocol
No
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
16
Results
Although there was no difference in the difficulty of climbing stairs due to the frequency of intervention, there was a tendency for it to decrease in both groups.
Results date posted
| 2023 | Year | 09 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No significant difference was observed between the two groups.
Participant flow
Research consent was obtained from 16 patients, but 2 patients discontinued the study. Reasons for discontinuation were ``I changed my mind'' and ``I wanted to concentrate on another treatment.'' A causal relationship with this study was not observed in either case. The subjects for analysis were 7 patients in the intensive intervention group and 7 patients in the regular intervention group.
Adverse events
No adverse events
Outcome measures
The main outcome was difficulty climbing stairs. Age, BMI, presence of diabetes, presence of orthopedic disease, etc. were investigated from medical records. Motor function was measured by measuring knee extension muscle strength, standing time on one leg, walking speed, etc.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 06 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051753
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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