UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059381 |
|---|---|
| Receipt number | R000067914 |
| Scientific Title | Wearable guided Physiotherapist Instruction Improves Exercise Capacity and Metabolic Function in Patient with Diabetic Kidney Disease |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/13 15:51:49 |
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Basic information
Public title
Wearable-guided Physiotherapist Instruction Improves Exercise Capacity and Metabolic Function in Patient with Diabetic Kidney Disease
Acronym
Effectiveness of DKD exercise instruction by physiotherapists
Scientific Title
Wearable guided Physiotherapist Instruction Improves Exercise Capacity and Metabolic Function in Patient with Diabetic Kidney Disease
Scientific Title:Acronym
Physiotherapists Improve DKD Exercise Capacity
Region
| Japan |
Condition
Condition
Diabetic Kidney Disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluated the impact of individualized exercise guidance provided by a physiotherapist using accelerometer-based devices to assess exercise capacity, physical function, renal outcomes, and metabolic parameters. The presented method is expected to aid in the development of more effective exercise intervention strategies for DKD, ultimately improving clinical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Six-minute walk distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise guidance by physiotherapists using wearable devices.
Interventions/Control_2
Physical assessment only
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
DKD patients attending Dokkyo Medical University Nikko Medical Centre as outpatients.
Key exclusion criteria
(1) ongoing hemodialysis, (2) acute coronary syndrome or stroke within the preceding 3 months, (3) inability to provide informed consent, and (4) any other contraindications to exercise as specified in current cardiac rehabilitation guidelines.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Momo |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of rehabilitation
Zip code
3211298
Address
145-1 Moritomo, Nikko, Tochigi
TEL
0288237000
momo@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Momo |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University Nikko Medical Center
Division name
Department of rehabilitation
Zip code
3211298
Address
145-1 Moritomo, Nikko, Tochigi
TEL
0288237000
Homepage URL
momo@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University Nikko Medical Center
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 Ethics Committee of the Dokkyo Medical University Nikko Medical Center
Address
145-1 Moritomo, Nikko, Tochigi
Tel
0288237000
n-y-7882@dokkyomed.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 | 10 | Month | 14 | 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
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2026 | 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 | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067914
