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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024409
Receipt No. R000028088
Scientific Title Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial
Date of disclosure of the study information 2016/10/14
Last modified on 2018/10/16

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Basic information
Public title Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial
Acronym Effects of an exercise program for elderly
Scientific Title Effects of a Renal Rehabilitation Exercise Program in Elderly Patients with End-Stage Renal Disease: A Controlled Clinical Trial
Scientific Title:Acronym Effects of an exercise program for elderly
Region
Japan

Condition
Condition chronic kidney disease of elderly patients
Classification by specialty
Nephrology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of an exercise program on the efficacy of dialysis and on functional and biochemical measurements in elderly patients with chronic kidney disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes efficiencyof dialysis, biochemical examination
Key secondary outcomes exercise tolerance, muscle force, QOL, ADL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Arobic exercise training on a bicycle ergometer within an hour for 2 days each week for 12 weeks. The duration of the exercise depended on their physical condition. Heart rate during exercise was determined by the Karvonen formula, applying 60% of the heart rate reserve and also using 11-13 rating of perceived exertion
Interventions/Control_2 Electrical stimulation group received electrical stimulation of leg extensors within an hour for 2 days each week for 12 weeks
Interventions/Control_3 received no intervention but standard treatment
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
60 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients of filling the following all criteria and having ability for agreement were as follows:
1) Chronic kidney disease stage 5
2) 60 years of age or more
Key exclusion criteria 1)Patients of acute coronary syndromes
2)Patients with cariogenic shock or worsening heart failure.
3)Unstable diabetic patients
Target sample size 39

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Misa Miura
Organization Tsukuba University of Technology
Division name Department of Health Science
Zip code
Address 4-12-7, Kasuga, Tsukuba City, Ibaraki prefecture, 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 Department of Health Science
Zip code
Address 4-12-7, Kasuga, Tsukuba City, Ibaraki prefecture, 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 The Ministry of Education, Culture, Sports, Science and Tchnology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tohoku University Graduate school of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北柏リハビリテーション病院、平山病院、あさおクリニック

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
published
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
2015 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 25 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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