UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057027 |
|---|---|
| Receipt number | R000065181 |
| Scientific Title | A study on the effects of training incorporating high-velocity pedaling exercise on glycemic control and muscle function in patients with type 2 diabetes. |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/14 11:46:56 |
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Basic information
Public title
A study on the effects of high-velocity pedaling training on glycemic control and muscles in patients with type 2 diabetes.
Acronym
The effects of high-velocity pedaling exercise in patients with type 2 diabetes.
Scientific Title
A study on the effects of training incorporating high-velocity pedaling exercise on glycemic control and muscle function in patients with type 2 diabetes.
Scientific Title:Acronym
The effects of high-velocity pedaling exercise in patients with type 2 diabetes.
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify which is more effective in improving glycemic control and muscle function, this study compares high-velocity pedaling exercise and high-resistance pedaling exercise as anaerobic resistance training combined with aerobic exercise for patients with diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle thickness and echo-intensity of the quadriceps muscle (VM, VL, VI, and RF), HbA1c, and blood glucose
Key secondary outcomes
Maximum isometric muscle strength of knee extensor, rate of force development (RFD), peak power, 10-meter walk test, 6-minute walk test, 30-second sit-to-stand test, Ten Step Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
A combination of 10 minutes of aerobic exercise and 5 minutes of high-velocity pedaling exercise, performed twice a week for 8 weeks.
Interventions/Control_2
A combination of 10 minutes of aerobic exercise and 5 minutes of low-velocity pedaling exercise, performed twice a week for 8 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with type 2 diabetes who are independent in activities of daily living and have stable blood glucose control (fasting blood glucose < 250 mg/dL, urinary ketones < moderate). Individuals who understand the purpose of the study and have no lower limb joint pain that would interfere with pedaling exercise.
Key exclusion criteria
Patients who have difficulty walking without assistive devices, those with central nervous system disorders, musculoskeletal disorders, or internal diseases that limit exercise. Patients with severe diabetic autonomic neuropathy. Patients whose blood glucose and blood pressure are unstable at rest (fasting blood glucose > 250 mg/dL or 70 mg/dL, systolic blood pressure > 180 mmHg or < 80 mmHg).
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Hiraoka |
Organization
Graduate School, Seijoh University
Division name
Department of Health Care Studies
Zip code
476-8588
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
TEL
052-601-6000
hiroki.hiraoka.0630@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Ochi |
Organization
Graduate School, Seijoh University
Division name
Department of Health Care Studies
Zip code
476-8588
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
TEL
052-601-6000
Homepage URL
ochi@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh University
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
The Research Ethics Committee of Seijoh University
Address
2-172 Fukinodai, Tokai-City, Aichi, Japan
Tel
052-601-6000
kenkyu-rinri@seijoh-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
| 2025 | Year | 02 | Month | 15 | 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
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 07 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065181
