UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057399 |
|---|---|
| Receipt number | R000065586 |
| Scientific Title | The Impact of Intensive Exercise Therapy on Exercise Self-Efficacy and Adherence in Patients with Type 2 Diabetes: A Prospective Cohort Study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/29 07:39:15 |
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Basic information
Public title
The Impact of Intensive Exercise Therapy on Motivation and Continuation of Exercise in Patients with Type 2 Diabetes
Acronym
"Diabetes Exercise Continuation Support" Study
Scientific Title
The Impact of Intensive Exercise Therapy on Exercise Self-Efficacy and Adherence in Patients with Type 2 Diabetes: A Prospective Cohort Study
Scientific Title:Acronym
Type 2 Diabetes Exercise Therapy Adherence Study
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the impact of inpatient exercise therapy on exercise self-efficacy and exercise adherence in patients with type 2 diabetes who are hospitalized for diabetes education at Osaka Saiseikai Ibaraki Hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The Exercise Adherence Rating Scale (EARS) and the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the continuity of exercise therapy. EARS will be assessed at discharge and 6 months after discharge, while IPAQ will be assessed at admission and 6 months after discharge.
Key secondary outcomes
At admission and discharge, patients' physical and mental functions will be evaluated using the Japanese version of the Self-Efficacy for Exercise Scale (SEE), the presence or absence of frailty (based on J-CHS criteria), the presence or absence of sarcopenia (based on AWGS2019), the presence or absence of locomotive syndrome, calf circumference, grip strength, 10-meter walking time, knee extension strength, grip strength (again), the two-step test, the Michigan Neuropathy Screening Instrument (MNSI), and ankle dorsiflexion range of motion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
During a multi-week hospital stay, intensive exercise therapy will be conducted as part of physical therapy. The program includes strength training (Borg Scale 14-16), aerobic exercise (Borg Scale 12-14), balance exercises (e.g., single-leg standing), and range of motion exercises (e.g., ankle dorsiflexion). Each session lasts about 40 minutes per day. On the first day, a physical therapist will customize the program based on the patient's physical function and lifestyle history.
1.Emphasize that exercise therapy is as important as pharmacotherapy and dietary therapy in managing diabetes. If needed, explain the acute and chronic effects of exercise.
2.Ask if the patient has an exercise habit. If not, gauge their willingness to begin and whether home-based exercise is an option.
3.If they already exercise, gather details (type, duration, timing) and offer adjustments if suitable. If they do not exercise but are open to starting, provide appropriate recommendations.
For patients struggling to adopt a routine, encourage them to track daily activity after discharge and gradually increase steps by about 500-1000 over time.
4.Regardless of exercise habits, advise all patients on simple bodyweight strength exercises tailored to their function, ensuring minimal fall risk.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes hospitalized for diabetes education at Osaka Saiseikai Ibaraki Hospital.
Key exclusion criteria
Patients who suffer from excessive pain or motor paralysis that makes various motor function evaluations difficult. In addition, patients with an HDS-R score of 20 or below, whose accuracy in completing questionnaires is expected to be significantly reduced.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Fudeyasu |
Organization
Osaka Saiseikai Ibaraki Hospital
Division name
Department of Rehabilitation Medicine
Zip code
567-0035
Address
2-1-45, Mitsukeyama, Ibaraki, Osaka 567-0035, Japan
TEL
072-622-8651
kenichi.fudeyasu@gmail.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Ito |
Organization
Osaka Saiseikai Ibaraki Hospital
Division name
Department of Rehabilitation Medicine
Zip code
567-0035
Address
2-1-45, Mitsukeyama, Ibaraki, Osaka 567-0035, Japan
TEL
072-622-8651
Homepage URL
youcan.one@gmail.com
Sponsor or person
Institute
Osaka Saiseikai Ibaraki Hospital
Institute
Department
Personal name
Funding Source
Organization
Public Interest Incorporated Foundation Osaka Gas Group Welfare Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Saiseikai Ibaraki Hospital Ethics Committee
Address
2-1-45, Mitsukeyama, Ibaraki, Osaka 567-0035, Japan
Tel
072-622-8651
info@ibaraki.saiseikai.or.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
大阪府済生会茨木病院 (大阪府)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 25 | Day |
Last modified on
| 2025 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065586
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/03/27 | 研究計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/03/27 | research data specification document.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/03/27 | case.csv |
Single case data URL
Value
https://center6.umin.ac.jp/ice/65586
