UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059091 |
|---|---|
| Receipt number | R000067596 |
| Scientific Title | Evaluation of Long-term Self-directed Exercise with Remote Monitoring for Glycemic Control in Type 2 Diabetes: An Exploratory Randomized Parallel-Group Trial |
| Date of disclosure of the study information | 2025/09/17 |
| Last modified on | 2025/09/16 01:48:31 |
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Basic information
Public title
Study on the Effects of Long-term Self-directed Exercise with Remote Monitoring on Blood Sugar Control in People with Type 2 Diabetes
Acronym
Study on the Effects of Long-term Self-directed Exercise with Remote Monitoring on Blood Sugar Control in People with Type 2 Diabetes
Scientific Title
Evaluation of Long-term Self-directed Exercise with Remote Monitoring for Glycemic Control in Type 2 Diabetes: An Exploratory Randomized Parallel-Group Trial
Scientific Title:Acronym
Evaluation of Long-term Self-directed Exercise with Remote Monitoring for Glycemic Control in Type 2 Diabetes: An Exploratory Randomized Parallel-Group Trial
Region
| Japan |
Condition
Condition
Type 2 Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Skeletal muscle plays a key role in glucose metabolism and the regulation of postprandial blood glucose. Age-related loss of muscle mass leads to decreased insulin sensitivity, contributing to impaired glucose metabolism and poor glycemic control. Resistance exercise has been shown to increase muscle mass and improve muscle function, and recent clinical trials have reported its beneficial effects on insulin resistance and glucose metabolism in patients with diabetes. However, in routine clinical practice, long-term adherence to exercise is often challenging, highlighting the need for effective intervention strategies. Therefore, this study aims to investigate the potential for improving glucose metabolism in patients with type 2 diabetes by implementing a system that remotely monitors patients' exercise and provides continuous support for sustained self-directed training.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 12 months
Key secondary outcomes
Skeletal muscle mass
Knee extension strength
Balance ability
Body mass index (BMI)
Duration of video viewing (usage of remote training content)
Medication status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
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
Resistance exercise: Squats, 10 reps x 3 sets and balance exercise: Single-leg stance, 1 min per leg x 3 sets
Frequency: At least 3 days per week
Duration: 15 minutes per day
Period: 1 year
Interventions/Control_2
Stretching exercises performed in sitting and standing positions
Targeting four muscle groups: quadriceps, hamstrings, triceps surae, gluteus medius
8 exercises (60 seconds per side, left and right)
Frequency: At least 3 days per week
Duration: 10 minutes per day
Period: 1 year
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients attending the internal medicine outpatient clinic at Mito General Hospital with a diagnosis of type 2 diabetes
Able to walk independently and perform activities of daily living (ADL) without assistance
Able to provide informed consent for participation in the study
Evaluated for physical function by a physical therapist at the outpatient clinic
Own a personal smartphone and able to freely access YouTube at their discretion (anytime, anywhere)
Able to view YouTube videos for approximately 15 minutes per day for 12 months using a smartphone (able to cover any data costs or expenses)
Key exclusion criteria
A) Patients with any of the following diabetic complications:
Proliferative diabetic retinopathy (patients stable after photocoagulation therapy are excluded)
Heart failure NYHA (New York Heart Association) class II or higher
B) Patients currently undergoing treatment for malignant tumors, including chemotherapy or radiation therapy (history of treatment only is allowed)
C) Patients taking corticosteroids
D) Patients with Cushing's syndrome or acromegaly, untreated or currently under treatment
E) Patients who have undergone gastrectomy
F) Patients with musculoskeletal disorders of the hip or knee resulting in inability to walk independently
G) Patients with central nervous system disorders causing paralysis (including incomplete paralysis)
H) Patients with neuropathy due to causes other than diabetes
I) Patients with cognitive impairment that makes it difficult to follow instructions (including impaired communication ability)
J) Patients with a history of regular exercise for more than 1 year
For example, aerobic exercise for 30 minutes per day at least 3 times per week, or resistance exercise 2-3 times per week
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | ito |
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospital
Division name
Department of Endocrinology and Metabolism
Zip code
310-0015
Address
3-2-7 Miyamachi, Mito-shi, Ibaraki-ken, Japan
TEL
+81-29-231-2371
jito.mgh@gmail.com
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Ito |
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospita
Division name
Department of Endocrinology and Metabolism
Zip code
310-0015
Address
3-2-7 Miyamachi, Mito-shi, Ibaraki-ken, Japan
TEL
+81-29-231-2371
Homepage URL
jito.mgh@gmail.com
Sponsor or person
Institute
Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospita
Institute
Department
Personal name
Funding Source
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospita
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba University Hospital Mito Clinical Education and Training Center, Mito Kyodo General Hospita
Address
3-2-7 Miyamachi, Mito-shi, Ibaraki-ken, Japan
Tel
+81-29-231-2371
jimujityou@mitokyodo-hp.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
筑波大学附属水戸地域医療教育センター総合病院水戸協同病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067596
