UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045680 |
|---|---|
| Receipt number | R000052141 |
| Scientific Title | Clinical study on exercise intolerance and multifaceted frailty in patients receiving hemodialysis and their clinical outcomes: a prospective cohort study |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2024/10/09 12:52:53 |
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Basic information
Public title
Clinical study on exercise intolerance and multifaceted frailty in patients receiving hemodialysis and their clinical outcomes: a prospective cohort study
Acronym
Clinical study on exercise intolerance and multifaceted frailty in patients receiving hemodialysis and their clinical outcomes
Scientific Title
Clinical study on exercise intolerance and multifaceted frailty in patients receiving hemodialysis and their clinical outcomes: a prospective cohort study
Scientific Title:Acronym
Clinical study on exercise intolerance and multifaceted frailty in patients receiving hemodialysis and their clinical outcomes
Region
| Japan |
Condition
Condition
End-stage kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the causal relationship between exercise capacity and various clinical outcomes
Basic objectives2
Others
Basic objectives -Others
Epidemiology
Elucidation of pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak oxygen uptake
Key secondary outcomes
Ventilation efficiency
Heart rate response during exercise
Other exhalation-gas analysis results
Physical function
Physical frailty
Social frailty
Protein-energy wasting
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients who are able to walk independently
Key exclusion criteria
Disagreement with test or study
Patients who can't go to the hospital on days without dialysis treatment
Untreated heart disease
Contraindications to exercise testing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Usui |
Organization
Kisen Hospital
Division name
Department of Rehabilitation
Zip code
1250041
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
TEL
03-3600-9007
usui@kisen.or.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Usui |
Organization
Kisen Hospital
Division name
Department of Rehabilitation
Zip code
1250041
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
TEL
03-3600-9007
Homepage URL
usui@kisen.or.jp
Sponsor or person
Institute
Department of rehabilitation, Kisen Hospital
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
Ethical Review Board of Kisen Hospital
Address
1-35-8 Higashikanamachi, Katsushika-ku, Tokyo, Japan
Tel
03-3600-9007
tomura@kisen.or.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
嬉泉病院（東京）、嬉泉クリニック（東京）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
201
Results
Various physiological reserves (peak oxygen uptake, heart rate reserve, peak work rate, and ventilatory efficiency) assessed by cardiopulmonary exercise testing in hemodialysis patients predicted all-cause mortality regardless of the severity of physical frailty.
On the other hand, physical frailty was also associated with all-cause mortality, but physical frailty did not maintain its association after adjustment for exercise capacity as assessed by the cardiopulmonary exercise testing.
Results date posted
| 2024 | Year | 10 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
peak oxygen uptake, heart rate reserve, peak work rate, and ventilatory efficiency, physical frailty
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 30 | Day |
Other
Other related information
This research will examine the causal relationship between exercise tolerance and the onset of physical frailty, and also compare the association of physical frailty and exercise intolerance with their respective clinical outcomes.
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2024 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052141
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/01/12 | 研究計画.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/01/12 | データ仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/01/12 | data.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/52141
