UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050549 |
|---|---|
| Receipt number | R000057566 |
| Scientific Title | Changes in Rectus Femoris Brightness in Patients with Type 2 Diabetes Comparison before and 2 weeks after the start of exercise therapy in educational inpatients and outpatients |
| Date of disclosure of the study information | 2023/03/09 |
| Last modified on | 2023/03/09 15:25:33 |
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Basic information
Public title
Changes in Rectus Femoris Brightness in Patients with Type 2 Diabetes
Comparison before and 2 weeks after the start of exercise therapy in educational inpatients and outpatients
Acronym
Changes in Rectus Femoris Brightness in Patients with Type 2 Diabetes
Comparison before and 2 weeks after the start of exercise therapy in educational inpatients and outpatients
Scientific Title
Changes in Rectus Femoris Brightness in Patients with Type 2 Diabetes
Comparison before and 2 weeks after the start of exercise therapy in educational inpatients and outpatients
Scientific Title:Acronym
Changes in Rectus Femoris Brightness in Patients with Type 2 Diabetes
Comparison before and 2 weeks after the start of exercise therapy in educational inpatients and outpatients
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
We will investigate and compare the amount of change in rectus femoris brightness in a short period of time before the start of exercise therapy and 2 weeks after the start of exercise therapy in patients with type 2 diabetes mellitus. This will verify the effects of educational inpatient and outpatient exercise therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of changes in rectus femoris brightness (before and 2 weeks after starting exercise therapy by educational inpatient group and outpatient group)
Key secondary outcomes
Knee extension muscle strength (weight ratio/torque value), thigh muscle thickness (ultrasound image), bioelectrical impedance method lower limb muscle mass, skeletal muscle mass index, body fat percentage, sural nerve conduction test (velocity/amplitude), predicted maximum change in oxygen uptake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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 | Maneuver |
Interventions/Control_1
Exercise therapy is performed in the order of muscle stretching, resistance exercise, and aerobic exercise. Resistance exercise is self-weight load resistance training, and 8 to 10 types of multi-joint exercises are performed in a sitting position, standing position, and on the mat on the floor. Aerobic exercise should be performed by walking on a treadmill. Treadmill walking uses a treadmill RUN600 (manufactured by techno gym), starting with a maximum heart rate of 40% calculated by the Karvonen method, increasing the load to 60% if possible, and aiming for 20 minutes. The exercise load is performed with a load higher than this guideline, referring to the Diabetes Physical Therapy Clinical Practice Guidelines. The duration of exercise should be at least 40 minutes per day.
Interventions/Control_2
Exercise therapy is performed in the order of muscle stretching, resistance exercise, and aerobic exercise. Resistance exercise is self-weight load resistance training, and 8 to 10 types of multi-joint exercises are performed in a sitting position, standing position, and on the mat on the floor. Aerobic exercise should be performed by walking on a treadmill. Treadmill walking uses a treadmill RUN600 (manufactured by techno gym), starting with a maximum heart rate of 40% calculated by the Karvonen method, increasing the load to 60% if possible, and aiming for 20 minutes. The exercise load is performed with a load higher than this guideline, referring to the Diabetes Physical Therapy Clinical Practice Guidelines. The duration of exercise should be at least 40 minutes per day.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects are type 2 diabetes patients aged 20 to 74 who receive exercise therapy at our hospital's educational inpatient and outpatient clinics.
Key exclusion criteria
Pre-proliferative retinopathy, proliferative retinopathy, overt nephropathy stage (stage 3) or later, ketosis state, acute and chronic cerebrovascular disease, bone and joint disease, musculoskeletal disease affecting movement or physical function Those who have a disease that may affect the condition, those who have an artificial joint or an intravascular stent, and those who have significant edema.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akifumi |
| Middle name | |
| Last name | Maruo |
Organization
Obata Clinic
Division name
Department of Rehabilitation
Zip code
708-0806
Address
452-6 Ota, Tsuyama City, Okayama Prefecture
TEL
0868-27-2111
obataclinicrehab@gmail.com
Public contact
Name of contact person
| 1st name | Akifumi |
| Middle name | |
| Last name | Maruo |
Organization
Obata Clinic
Division name
Department of Rehabilitation
Zip code
708-0806
Address
452-6 Ota, Tsuyama City, Okayama Prefecture
TEL
0868-27-2111
Homepage URL
obataclinicrehab@gmail.com
Sponsor or person
Institute
Obata Clinic
Institute
Department
Personal name
Funding Source
Organization
Obata Clinic
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
Obata Clinic
Address
452-6 Ota, Tsuyama City, Okayama Prefecture
Tel
0868-27-2111
obataclinicrehab@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
0069
Org. issuing International ID_1
Okayama Healthcare Professional University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 09 | 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
| 2023 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057566
