UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055064 |
|---|---|
| Receipt number | R000062902 |
| Scientific Title | A Prospective Interventional Study of the Efficacy of Systematic Therapeutic Instruction Using a Novel Wearable Device in Kidney Transplant Recipients. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/07/24 15:03:19 |
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Basic information
Public title
A Prospective Interventional Study of the Efficacy of Systematic Therapeutic Instruction Using a Novel Wearable Device in Kidney Transplant Recipients.
Acronym
A Prospective Interventional Study of the Efficacy of Systematic Therapeutic Instruction Using a Novel Wearable Device in Kidney Transplant Recipients.
Scientific Title
A Prospective Interventional Study of the Efficacy of Systematic Therapeutic Instruction Using a Novel Wearable Device in Kidney Transplant Recipients.
Scientific Title:Acronym
A Prospective Interventional Study of the Efficacy of Systematic Therapeutic Instruction Using a Novel Wearable Device in Kidney Transplant Recipients.
Region
| Japan |
Condition
Condition
Kidney Transplant Recipients
Classification by specialty
| Nephrology | Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether systematic therapeutic guidance using a novel wearable device in kidney transplant recipients is beneficial in preventing frailty and sarcopenia and preserving allograft renal function in kidney transplant recipients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Contribution of increased physical activity to allograft renal function
Key secondary outcomes
1) Improvement of sedentary behavior (physical inactivity) during waking period and its contribution to allograft renal function (*High physical inactivity group: sedentary behavior (physical inactivity) during waking period of 10 hours or more)
2) Evaluation of achievement rates with respect to exercise regimens in kidney transplant patients.
3) Evaluation of changes in physical activity, frailty score, muscle strength, muscle mass, SPPB, and maximal oxygen uptake by wearing physical activity monitoring equipment, and analysis of factors associated with increases.
4) Association of increased physical activity and improved physical inactivity with rate of change in proteinuria, allograft renal function loss of allograft function, and CAVI.
5) Protein intake in relation to muscle mass and strength
6) Impact of Increased Physical Activity and Improved Physical Inactivity on Metabolome Analysis in Transplant Recipients: Evaluation of Increase/Decrease in Aging-Related Proteins.
7) Effects of Increased Physical Activity and Improved Physical Inactivity on Tubular Aging in Transplanted Kidneys
8) Assessment of the incidence of adverse events associated with increased physical activity.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Kidney Transplant Recipients
Key exclusion criteria
1) Under 18 years of age
2) Patients with significant difficulty in receiving therapeutic guidance
3) Patients for whom exercise therapy is prohibited due to ischemic heart disease, lower limb arterial occlusive disease, stroke, etc.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sofue |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
0878912150
sofue.tadashi@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sofue |
Organization
Kagawa University Hospital
Division name
Department of Nephrology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
TEL
0878912150
Homepage URL
sofue.tadashi@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
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
Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, Japan
Tel
0878912150
chiken-b.@med.kagawa-u.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
| 2024 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062902
