UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059626 |
|---|---|
| Receipt number | R000068200 |
| Scientific Title | The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients |
| Date of disclosure of the study information | 2025/11/10 |
| Last modified on | 2025/11/03 19:03:35 |
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Basic information
Public title
The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients
Acronym
The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients
Scientific Title
The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients
Scientific Title:Acronym
The Effect of Physical Activity on Postoperative Outcomes in Renal Transplant Patients
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology | Surgery in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure Physical activity levels during hospitalization in kidney transplant patients using wearable devices and clarify the impact of activity levels on physical function at discharge and the occurrence of postoperative complications.
Basic objectives2
Others
Basic objectives -Others
To the best of our knowledge, There are no studies targeting Renal transplant patients have been conducted in Japan.
At our hospital, we assess physical function before kidney transplantation and initiate unrestricted rehabilitation intervention the day after surgery, promoting early ambulation.
However, rehabilitation protocols for kidney transplant patients remain unestablished, and appropriate activity levels are currently unclear.
The activity monitor used is the HJA-750C Active style Pro (manufactured by OMRON). It is worn on the waist using a belt, excluding sleep and bathing times, and measures physical activity data every 10 seconds across three intensity levels.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Activity Levels by Activity Intensity During Hospitalization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Attach the device to the waist to measure activity levels. The patients wear it the day after surgery and keep it on at all times except during sleep and bathing. The wearing period is 10 days starting the day after surgery.
Postoperatively, standard rehabilitation interventions will be implemented for all subjects.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized patients undergoing Renal transplantation at our institution (regardless of underlying disease or prior dialysis history)
2) Patients aged 20 years or older at the time of consent acquisition (gender not restricted) (Note the subject's age when evaluating the IPAQ)
3) Research subjects who, after receiving sufficient explanation regarding participation in this study, provided written informed consent of their own free will
Key exclusion criteria
Patients meeting any of the following criteria shall not be included in this study:
1) Patients with a history of myocardial infarction
2) Patients with a history of coronary revascularization (PCI or CABG)
3) Patients with concomitant unstable angina
4) Patients with a history of cerebrovascular disease (excluding asymptomatic lacunar infarction)
5) Patients with a history of hospitalization due to heart failure
6) Patients with severe liver disease (AST (GOT) or ALT (GPT) 100U or more)
7) Women who are pregnant or may be pregnant
8) Women who are breastfeeding
9) Other patients deemed unsuitable as study subjects by the principal investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Sato |
Organization
Shonan Kamakura General Hospital
Division name
Rehabilitation Department
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura City, Kanagawa Prefecture
TEL
0467-46-1717
reha@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Nishimura |
Organization
Shonan Kamakura General Hospital
Division name
Rehabilitation Department
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura City, Kanagawa Prefecture
TEL
0467-46-1717
Homepage URL
reha@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital(Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mirai Iryo Research Center Inc.
Address
Tokyo-do Chiyoda Building,3-1,Kudan-minami 1-chome Chiyoda-ku, Tokyo
Tel
0332634801
mirai-ec1@mirai-iryo.com
Secondary IDs
Secondary IDs
YES
Study ID_1
TGE02803-024
Org. issuing International ID_1
Shonan Kamakura General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
湘南鎌倉総合病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 10 | 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
| 2025 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2028 | 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 | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068200
