UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* 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 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
Japan

Condition
Condition CKD stage5
Classification by specialty
Medicine in general Nephrology Rehabilitation medicine
Adult
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
Maneuver Other
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
65 years-old <
Age-upper limit
95 years-old >
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
1st name
Middle name
Last name Misa Miura
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
Email m.miura@k.tsukuba-tech.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Misa Miura
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
Email 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
Email

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
2018 Year 04 Month 11 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 Completed
Date of protocol fixation
2011 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 11 Day
Last modified on
2018 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.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


Contact us.