UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052278 |
|---|---|
| Receipt number | R000059680 |
| Scientific Title | Intervention study using an exercise program for chronic kidney disease patients with sarcopenia/frail |
| Date of disclosure of the study information | 2023/09/22 |
| Last modified on | 2023/09/22 13:08:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intervention study using an exercise program for chronic kidney disease patients with sarcopenia/frail
Acronym
Intervention study using an exercise program for chronic kidney disease patients with sarcopenia/frail
Scientific Title
Intervention study using an exercise program for chronic kidney disease patients with sarcopenia/frail
Scientific Title:Acronym
Intervention study using an exercise program for chronic kidney disease patients with sarcopenia/frail
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that "in chronic kidney disease patients with sarcopenia/frail, an exercise program intervention reduces sarcopenia/frail," i.e., "muscle strength increases after a certain period of time after the start of the exercise program intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 times Chair stand-up seconds
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants will receive guidance on the exercise program through personal training for one hour per session.
Exercise instruction will be provided on day 5, one week after day 5, one month after day 5, and every month thereafter, for a total of 8 sessions.
The exercise protocol consists of one exercise for the entire lower limb and three exercise for each of the thigh, lower leg, and upper limb.
The menu will be updated monthly according to the subject's strength.
Home exercises will be performed at least twice a week.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
eGFR less than or equal to 45 mL/min/1.73 m2 at enrollment
Patients with urinary protein stores of 3.5 g/day or less or urinary protein of 3.5 g/gcre or less at any time at the time of enrollment.
Cases with sarcopenia/frail at the time of enrollment Grip strength and leg circumference are used as criteria for sarcopenia/frail complications.
Grip strength is less than 28 kg in men and less than 18 kg in women.
Leg circumference is less than 34 cm in men and 33 cm in women.
Key exclusion criteria
Cases of nephrotic syndrome
Patients with cardiovascular complications or motor dysfunction at the time of enrollment who are deemed by the physician to be ineligible for exercise therapy
Patients who are deemed by the physician to be unable to perform exercise therapy at home.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | kunihiro |
| Middle name | |
| Last name | yamagata |
Organization
University of Tsukuba, Faculty of Medicine and Medical Sciences
Division name
nephrology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba City, Ibaraki Prefecture
TEL
0298533202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | takuya |
| Middle name | |
| Last name | harada |
Organization
Tsukuba University Hospital
Division name
nephrology
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
TEL
0298533613
Homepage URL
k-yamaga@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
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
Tsukuba Clinical Research Development Organization
Address
2-1-1 Amakubo, Tsukuba City, Ibaraki Prefecture
Tel
0298533914
t-credo.adm@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
| 2023 | Year | 09 | Month | 22 | 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
| 2023 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | 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
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059680
