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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000032202 |
Receipt No. | R000036726 |
Scientific Title | Effects of renal rehabilitation exercise program in patients with end stage renal disease |
Date of disclosure of the study information | 2018/04/11 |
Last modified on | 2018/04/11 |
Basic information | ||
Public title | Effects of renal rehabilitation exercise program in patients with end stage renal disease | |
Acronym | Effects of renal rehabilitation for end stage renal disease | |
Scientific Title | Effects of renal rehabilitation exercise program in patients with end stage renal disease | |
Scientific Title:Acronym | Effects of renal rehabilitation for end stage renal disease | |
Region |
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Condition | |||||
Condition | CKD stage5 | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study aimed to evaluate and compare the effects of electrical stimulation for lower limbs on muscle strength, dialysis efficiency, and serum inflammatory markers, including cytokine factors. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase III |
Assessment | |
Primary outcomes | muscle power |
Key secondary outcomes | dialysis efficiency, serum phosphorus, biochemical tests in cluding inflammatory markers |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -but assessor(s) are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | YES |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | Central registration |
Intervention | |||
No. of arms | 3 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Subjects underwent electrical stimulation for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks. | ||
Interventions/Control_2 | They exercised for 1 hour or less during the first half of the HD session twice a week of 12 consecutive weeks on an ergometer load. | ||
Interventions/Control_3 | A group that underwent standard hemodialysis treatment without exercise programs | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The subjects were stable,maintenance hemodialysis patients who underwent outpatient hemodialysis treatment of three times a week | |||
Key exclusion criteria | Acute coronary syndrome, particularly unstable angina and acute myocardial infarction; systolic blood pressure overed 180 mmHg or diastolic blood pressure overed 110 mmHg; and patients who were determined as inappropriate for the study by the attending physician. | |||
Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tsukuba University of Technology | ||||||
Division name | Faculty of Health Science | ||||||
Zip code | |||||||
Address | 4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan | ||||||
TEL | 029-858-9552 | ||||||
m.miura@k.tsukuba-tech.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tsukuba University of Technology | ||||||
Division name | Faculty of Health Science | ||||||
Zip code | |||||||
Address | 4-12-7,Kasuga,TsukubaCity,Ibaraki,Japan | ||||||
TEL | 029-858-9552 | ||||||
Homepage URL | |||||||
m.miura@k.tsukuba-tech.ac.jp |
Sponsor | |
Institute | Tsukuba University of Technology |
Institute | |
Department |
Funding Source | |
Organization | Tsukuba University of Technology |
Organization | |
Division | |
Category of Funding Organization | Government offices of other countries |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | Tohoku University |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | 2011-120-1 |
Org. issuing International ID_1 | Tohoku University |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 北柏リハビリテーション病院,平山病院 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
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Date trial data considered complete |
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036726 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |