UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057257 |
|---|---|
| Receipt number | R000059125 |
| Scientific Title | A study of the effect of outpatient exercise therapy by physical therapists on diabetes management |
| Date of disclosure of the study information | 2025/03/12 |
| Last modified on | 2025/03/11 14:50:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of the effect of outpatient exercise therapy by physical therapists on diabetes management
Acronym
A study of the effect of outpatient exercise therapy by physical therapists on diabetes management
Scientific Title
A study of the effect of outpatient exercise therapy by physical therapists on diabetes management
Scientific Title:Acronym
A study of the effect of outpatient exercise therapy by physical therapists on diabetes management
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term effect of regular outpatient exercise therapy provided by physical therapists on diabetes management in people with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Term for evaluation
At baseline, at 12 weeks, and at 24 weeks
Evaluation items
HbA1c
Key secondary outcomes
Term for evaluation
At baseline, at 12 weeks, and at 24 weeks
Evaluation items
Physical function (grip strength, knee extensor strength, five times sit-to-stand test, walking speed)
Urinalysis data (urinary Alb, eGFR, urinary Cr)
Physical activity (number of steps, energy expenditure, moderate-to-vigorous intensity physical activity)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Outpatient physical therapy is provided every 4 weeks for 24 weeks in addition to oral guidance using exercise materials.
Interventions/Control_2
Exercise materials is distributed at the first session, and no exercise instruction is provided thereafter.
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
| 60 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Outpatients with type 2 diabetes
2. Diabetes duration: at least 24 weeks
3. HbA1c: between 7.0% and 10.0%
4. Body mass index (BMI): between 22.0 and 35.0
Key exclusion criteria
1. Patients who have been already receiving regular exercise instruction from physical therapists
2. Patients who already have sufficient amount of exercise (for at least 30 minutes per session and at least twice a week / resistance exercise at least twice a week)
3. Patients who have been receiving insulin therapy or plan to introduce insulin therapy during the period
4. Patients who have changed their medication or diet within 3 months prior to the start of observation, or who are scheduled to change their medication or diet during the period
5. Patients with large fluctuations in HbA1c or body weight (HbA1c: plus or minus 0.5% or more, body weight: plus or minus 3 kg or more) within 3 months prior to the start of observation
6. Patients within 4 weeks of discharge from diabetes education hospitalization
7. Patients with advanced diabetic complications (retinopathy except simple retinopathy, nephropathy stage IV or later, severe neuropathy or foot involvement)
8. Patients with a fasting blood glucose level of 250 mg/dL or higher and a urine ketone level moderately positive or higher at screening
9. Patients with severe hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg in the resting sitting position)
10. Patients who are considered to have difficulty with active exercise load due to concomitant or pre-existing cerebrovascular, cardiovascular, respiratory, or locomotor diseases
11. Patients with acute or severe infections
12. Patients with concomitant or pre-existing malignancy (but may be included if they have not required treatment for at least the past 5 years and have no evidence of recurrence)
13. Patients who are deemed to be cognitively impaired and unable to perform the study
14. Patients who are certified as needed support or needed long-term care
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
h-honda@un.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Honda |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Hojo, Daito, Osaka
TEL
072-863-5043
Homepage URL
h-honda@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
The Nakatomi Foundation
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
Shijonawate Gakuen University
Address
5-11-10 Hojo, Daito, Osaka
Tel
072-863-5043
k-hanada@un.shijonawate-gakuen.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 | 03 | Month | 12 | 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 | 12 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | 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 | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059125
