UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052441 |
|---|---|
| Receipt number | R000059854 |
| Scientific Title | Relationship between Walking and Cognitive function in Japanese elderly type2 diabetic patients Part2 |
| Date of disclosure of the study information | 2023/10/08 |
| Last modified on | 2023/10/08 13:44:56 |
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Basic information
Public title
Toranomon Walk-Training Trial Part2
Acronym
TWTT part2
Scientific Title
Relationship between Walking and Cognitive function in Japanese elderly type2 diabetic patients Part2
Scientific Title:Acronym
TWTT part2
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, the number of elderly diabetic patients is increasing. As people age, diabetic patients gradually experience a decline in physical function, resulting in a decrease in activity, a decline in muscle mass and strength, and an increase in insulin resistance, which subsequently leads to geriatric syndrome. For many years, the Japan Diabetes Association has supported patients' exercise therapy by running walking groups and walk rallies centered on patient groups. Walking exercise is the most familiar form of exercise therapy for diabetic patients, and is easy to start and continue. Muscle activity throughout the body and stimulation of the nervous system brought about by walking play an extremely important role in maintaining not only the patient's motor function but also the higher functions of the brain. Walking while enjoying the seasonal scenery and interacting with members of patient associations from other hospitals also helps improve mental health. In this respect, the fact that the Japan Diabetes Association has operated walking groups for many years and that many members have participated can be considered to have made a major contribution to diabetes treatment activities in Japan. Older patients show a decline in walking ability. With research grant from the Japan Diabetes Association (clinical research grant to extend the healthy life expectancy of elderly people with diabetes), we have evaluated the walking ability of elderly diabetic patients starting in 2021(Part 1 Cross-sectional study). Continuing from Part 1, we planed an intervention study (Part 2) with the outcome indicator being to suppress the decline in physical function by providing walking guidance by the rehabilitation department and nutritional guidance by registered dietitians for groups at high risk of geriatric syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in walking speed 1 year after intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise/diet intervention group: At the beginning of the intervention, the rehabilitation department will provide face-to-face instruction on a rehabilitation program that can be implemented at home, and the nutrition department will provide nutritional guidance. Six months after the start of the intervention, a simplified physical function assessment and nutritional guidance will be conducted during face-to-face rehabilitation. Twelve months after the start of the intervention, physical function evaluations similar to those conducted in Part 1 will be conducted to examine the effects of the intervention.
Interventions/Control_2
Exercise (remote)/dietary intervention group: At the start of the intervention, we will provide the necessary items for remote rehabilitation intervention (exercise prescription DVD and playback player rental), and provide nutrition consultation at the nutrition department. Nutritional guidance will be provided 6 months after the start of the intervention. Twelve months after the start of the intervention, physical function evaluations similar to those conducted in Part 1 will be conducted to examine the effects of the intervention.
Participants will be divided into two groups and will undergo a 12-month intervention. Cognitive function and frailty will be evaluated before and after the intervention.
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
| 66 | years-old | <= |
Age-upper limit
| 76 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes attending Toranomon Hospital who were between 65 and 75 years old at the time of participation in Part 1 study and who provided written consent to participate in Part 2.
Key exclusion criteria
Cases with impaired walking due to organ disease, etc., cases undergoing treatment for malignant tumors, cases on oral steroids, and cases with BNP of 100 pg/mL or higher will be excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | YASUMICHI |
| Middle name | |
| Last name | MORI |
Organization
Toranomon Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, JAPAN
TEL
03-3588-1111
ymori-metab@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | TAKAYASU |
| Middle name | |
| Last name | UCHIDA |
Organization
Toranomon Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo, JAPAN
TEL
03-3588-1111
Homepage URL
t.uchida@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital Clinical Trials/Clinical Research Department
Address
2-2-2 Toranomon, Minato-ku, Tokyo, JAPAN
Tel
03-3588-1111
chiken-jim@toranomon.gr.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
虎の門病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 08 | 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
72
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
| 2022 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2023 | Year | 10 | Month | 08 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059854
