UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055825 |
|---|---|
| Receipt number | R000063804 |
| Scientific Title | Effects of exercise training on kidney function in middle-aged and older adults |
| Date of disclosure of the study information | 2024/10/14 |
| Last modified on | 2025/05/10 11:20:24 |
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Basic information
Public title
Effects of exercise training on kidney function in middle-aged and older adults
Acronym
The Aging Kidney and Exercise Training Study
Scientific Title
Effects of exercise training on kidney function in middle-aged and older adults
Scientific Title:Acronym
The Aging Kidney and Exercise Training Study
Region
| Japan |
Condition
Condition
Middle-aged and older adults
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of 1-year multicomponent exercise training on kidney function and health-related outcomes in middle-aged and older adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated glomerular filtration rate (eGFR) slope
Key secondary outcomes
1. Phosphate metabolism
2. Cardiovascular measurements
3. Renal duplex ultrasonography
4. Endothelial function
5. Blood biomarkers
6. Urinary biomarkers
7. Physical function
8. Daily physical activity and sedentary behavior
9. Body composition
10. Magnetic resonance imaging
11. Cognitive function
12. Dietary assessments
13. Sleep, Mental, and Pain status
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1-year multicomponent exercise training program
Interventions/Control_2
1-year stretching program
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals who participated in the 5-year follow-up of the prospective cohort study (Registry No. UMIN000034741) conducted earlier.
2) Individuals who fall under GFR stages 1 to 3b (estimated glomerular filtration rate of 30 mL/min/1.73 m^2 or higher).
3) Individuals who can agree to the terms of use of the Tsukuba Memorial Hospital Medical Fitness Center Phoenix.
Key exclusion criteria
1) Individuals who have been advised by a doctor to restrict physical activity.
2) Individuals who are currently suffering from a serious illness or have a history of severe diseases (e.g., cardiovascular diseases).
3) Individuals who are judged to have issues that would hinder the progression of the study.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-3210
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Keisei |
| Middle name | |
| Last name | Kosaki |
Organization
University of Tsukuba
Division name
Institute of Health and Sports Science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-5990
Homepage URL
kosaki.keisei.gm@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1) National Institute of Advanced Industrial Science and Technology
2) Jichi Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Institute of Medicine, University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel
+81-29-853-3308
sien.ningenss@un.tsukuba.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 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2024 | Year | 10 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063804
