UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038402 |
|---|---|
| Receipt number | R000043762 |
| Scientific Title | Intradialytic Exercise Training in Elderly People Undergoing Hemodialysis: A Randomized clinical trial. |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2023/05/13 11:09:49 |
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Basic information
Public title
Intradialytic Exercise Training in Elderly People Undergoing Hemodialysis: A Randomized clinical trial.
Acronym
Intradialytic Exercise Training in Elderly People Undergoing Hemodialysis: A Randomized clinical trial.
Scientific Title
Intradialytic Exercise Training in Elderly People Undergoing Hemodialysis: A Randomized clinical trial.
Scientific Title:Acronym
Intradialytic Exercise Training in Elderly People Undergoing Hemodialysis: A Randomized clinical trial.
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study is to examine the effects of exercise training in elderly patients undergoing hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
leg extremity muscle strength, hand grip strength, 10m gait speed, and Short physical performance battery, at pre and post 6month.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Aerobic and resistance exercise during hemodialysis 3 times per week, 6 month.
Interventions/Control_2
Normal treatment of homodialysis
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
| 70 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CKD Patients undergoing hemodialysis over 6 month.
patients who have stable hemodialysis treatment
Patients with written informed consent after receiving a full explanation
Patients with independent ADL without apparent dementia
Key exclusion criteria
Patients after kidney transplant
Patients with peritoneal dialysis
Patient judged to be inappropriate by the charge doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453, Mikatahara, Kita-ku, Hamamatsu, Shizuoka
TEL
0534391400
yabe0909@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yabe |
Organization
Seirei Christopher University
Division name
Department of Rehabilitation
Zip code
433-8558
Address
3453, Mikatahara, Kita-ku, Hamamatsu, Shizuoka
TEL
0534391400
Homepage URL
yabe0909@gmail.com
Sponsor or person
Institute
Sanaru Sun Clinic
Institute
Department
Personal name
Funding Source
Organization
Sanaru Sun Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Christopher University
Address
3453, Mikatahara, Kita-ku, Hamamatsu, Shizuoka
Tel
0534391400
yabe0909@gmail.com
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
さなるサンクリニック(静岡県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://gyosekidb.seirei.ac.jp:8083/scuhp/KgApp?kyoinId=ymbkgmgmggy
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article/comments?id=10.1371/journal.pone.0257918
Number of participants that the trial has enrolled
101
Results
The group comparison revealed no differences in any baseline characteristics between the two groups. The SPPB score improved in the exercise group. Conversely, no significant changes were observed in the control group. No significant difference was observed in the LES or the 10-m walking speed between the two groups at baseline or after an intervention.
Results date posted
| 2022 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 22 | Day |
Baseline Characteristics
The group comparison revealed no differences in any baseline characteristics between the two groups. The SPPB score improved in the exercise group. Conversely, no significant changes were observed in the control group. No significant difference was observed in the LES or the 10-m walking speed between the two groups at baseline or after an intervention.
Participant flow
Among the 101 randomly assigned patients, 17 (16.8%) were unavailable for follow-up testing: 10 did not complete the final evaluations, two did not continue for medical reasons, and five died during the 6-month follow-up period . Thus, 84 patients (44 in the exercise group and 40 in the control group) were included in the analysis.
Adverse events
non
Outcome measures
Lower extremity muscle strength
10m walking speed
Short physical performance battery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043762
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